MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-02-12 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[1426090]
The user stated their results did not compare well with the peer group results for a therapeutic drug linearity survey. Of the data provided, the carbamazepine results for three samples, the vancomycin results for five samples and the valproic acid results for four sample were discrepant. All results are in ug/ml. The carbamazepine results were: sample 1 : 7. 7 and 7. 8 for a mean of 7. 75, the peer mean was 9. 37. Sample 2: 11. 0 and 10. 9 for a mean of 10. 95, the peer was 12. 82. Sample 3: 14. 0 and 13. 7 for a mean of 13. 85, the peer mean was 15. 96. The vancomycin results were: sample 1: results were 4. 3 and 4. 6 for a mean of 4. 45, the peer mean was 3. 25. Sample 2: results were 50. 5 and 50. 6 for a mean of 50. 55, the peer mean was 41. 27. Sample 3: results were 72. 9 and 72. 7 for a mean of 72. 80, the peer mean was 60. 43. Sample 4: results were 92. 0 and 91. 7 for a mean of 91. 87, the peer mean was 76. 65. Sample 5: results were 117. 7 and 114. 3 for a mean of 116. 00, the peer mean was 90. 65. The valproic acid results were: sample 1: results were 73. 4 and 78. 0 for a mean of 75. 70, the peer mean was 70. 89. Sample 2: results were 99. 6 and 97. 2 for a mean of 98. 40, the peer mean was 98. 80. Sample 3: results were 120. 1 and 112. 0 for a mean of 116. 05, the peer mean was 125. 80. Sample 4: results were 141. 6 and 153. 8 for a mean of 147. 70, the peer mean was 147. 13. The samples were tested in microcups. The carbamazepine reagent lot number was 584903, the vancomycin reagent lot number was 14455000 and the valproic acid lot number was 14454900. The user retested the same samples on (b) (6) 2010 and (b) (6) 2010 with new lot numbers of reagents and results were within the acceptable range. The carbamazepine reagent lot number 587925. The vancomycin and valproic acid lot number were not provided. The carbamazepine repeat results were: sample 1 : 9. 714 and 9. 770. Sample 2: 13. 305 and 13. 363. Sample 3: 16. 381 and 17. 139. The vancomycin results were: sample 1: 4. 7 and 5. 1. Sample 2: 41. 6, 42. 3 and on (b) (6) 2010 was 40. 4. Sample 3: 61. 2, 61. 3 and on (b) (6) 2010 was 57. 0. Sample 4: 78. 2, 79. 9 and on (b) (6) 2010 was 71. 6. Sample 5: 96. 5 with a data flag, 100. 3 with a data flag and on (b) (6) 2010 was 86. 3. The valproic acid results were: sample 1: 89. 8, 92. 0 and on (b) (6) 2010 was 77. 0. Sample 2: 123. 0, 125. 0 and on (b) (6) 2010 was 103. 4. Sample 3: 164. 9 with a data flag, 171. 9 with a data flag and on (b) (6) 2010 was 120. 9. Sample 4: 196. 5 with a data flag, 171. 9 with a data flag and on (b) (6) 2010 was 143. 5. The user stated no patient samples were affected by the issue. The user stated he felt the cause may be a reagent issue or a poor calibration. The field application specialist calibrated the assays with a new calibrator and recovered qc values close to the mean. He then retested the linearity material and results recovered in range.
Patient Sequence No: 1, Text Type: D, B5
[8508821]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-00979 |
| MDR Report Key | 1598505 |
| Report Source | 05,06 |
| Date Received | 2010-02-12 |
| Date of Report | 2010-02-12 |
| Date of Event | 2009-12-01 |
| Date Facility Aware | 2010-01-19 |
| Date Mfgr Received | 2010-01-19 |
| Date Added to Maude | 2010-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | HITACHI HIGH TECH. CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | KLT |
| Date Received | 2010-02-12 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-12 |