MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-06-28 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[78609503]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[78609504]
The customer obtained questionable high test results for an unspecified number of patient samples using the phos2 phosphate (inorganic) ver. 2 (phos2) assay on the cobas 6000 c (501) module (c501). The customer repeated a "few" patient samples to check for discrepancies and issued corrected reports. One example of erroneous patient data was provided. All results are in units of mg/dl, and all were released outside the laboratory. The initial result was 11. 1. The sample was repeated on a second c501 analyzer with a result of 7. 6, and on a third analyzer with a result of 7. 7. The result of 7. 6 was deemed correct and a corrected report was issued. No adverse event occurred. The phos2 reagent lot number is 22584501 with an expiration date of 07/31/2018. The field service representative adjusted the gear pump pressure, replaced reagent probes, and verified rinse mechanism levels. He performed a precision check that passed. The customer performed quality controls which passed. Investigation activities are ongoing.
Patient Sequence No: 1, Text Type: D, B5
[120158624]
The root cause was the misadjusted gear pump, which led to reagent carryover and the discrepant results. The issue was resolved by the service activities. A general reagent issue could be excluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01348 |
| MDR Report Key | 6673279 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-28 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-06-13 |
| Date Mfgr Received | 2017-06-14 |
| Date Added to Maude | 2017-06-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| 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 | CEO |
| Date Received | 2017-06-28 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-28 |
| Model Number | C501 |
| Catalog Number | 05860636001 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-28 |