MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-13 for COBAS 6000 CORE 05036453001 manufactured by Roche Diagnostics.
[17099430]
The customer received a questionable c-reactive protein gen. 3 (crp) result on their c501 analyzer. All tests were performed on the same c501 analyzer using serum samples. The patient's initial crp result was 9. 9 mg/dl accompanied by a data flag. The initial result was auto-verified by the lis and released to the physician. The customer called the physician and instructed them there might be a problem with the result because the serum indices associated with the test were flagged. The customer advised the physician not to do anything with the crp result until they investigate. The customer repeated the patient's sample and the result was 4. 4 mg/dl accompanied by a data flag. This repeat result was auto-verified and released from the laboratory. The customer repeated the sample for a third time and the result was 4. 4 mg/dl accompanied by a data flag. The customer believed the repeat result of 4. 4 mg/dl to be correct. The patient was not treated based on the erroneous result. There were no adverse affects from this event. The crp reagent lot number was 64881401 and the expiration date was 11/30/2011. The customer declined a service visit.
Patient Sequence No: 1, Text Type: D, B5
[17406411]
.
Patient Sequence No: 1, Text Type: N, H10
[20206721]
A specific root cause could not be identified as the reaction kinetics were not available for further investigation. Based upon information provided, the initial crp result was accompanied by a data flag notifying the user the result was high, outside of the reference range set for the assay. The serum indices for the same sample were flagged with a sample flag, which is triggered by the clot sensor. The sample clot sensor works by comparing the pressure to a known value; if it is exceeded an alarm is issued. In this case an alarm was issued. It seems that the clot causing the alarm stuck to the sample needle and was transported to the cuvette when the crp measurement took place leading to the high initial result. After the clot was removed, the re- runs generated correct results. This assumption could not be confirmed because the reaction kinetics were not available for investigation. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-05379 |
| MDR Report Key | 2292697 |
| Report Source | 05,06 |
| Date Received | 2011-10-13 |
| Date of Report | 2012-03-09 |
| Date of Event | 2011-09-24 |
| Date Mfgr Received | 2011-09-26 |
| Date Added to Maude | 2011-10-13 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 CORE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DCN |
| Date Received | 2011-10-13 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2011-10-13 |