MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-19 for COBAS 8000 C (701) MODULE C701 05641489001 manufactured by Roche Diagnostics.
[73262747]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[73262748]
The customer experienced issues with their quality control results for crpl3 c-reactive protein gen. 3 and repeated testing of the quality material several times before finally stopping testing on this analyzer. The customer repeated the samples that had been tested for crp on this analyzer on another analyzer in the laboratory. Of the data provided for approximately 250 samples, the results for 94 samples were discrepant. Refer to the attachment to the medwatch for all patient data. The column labeled "preliminary result" is the erroneous initial result. The column labeled "result" is the repeat result from the other analyzer. The unit of measure was not provided. Information concerning if any erroneous result was reported outside the laboratory was requested but it was unknown. There was no allegation of an adverse event. The reagent lot number was 202453. The expiration date was requested but was not provided. The field service representative checked the gear pump pressure, adjusted wash levels, and removed and cleaned the ultrasonic mixers. Qc was performed and was acceptable.
Patient Sequence No: 1, Text Type: D, B5
[79048689]
Initially the customer reported they had further issues with the crp assay after the service visit. However, later they confirm that the issue was resolved. A specific root cause could not be determined based on the available information. Additional information for further investigation was requested but not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00824 |
| MDR Report Key | 6504261 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-19 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-04-02 |
| Date Mfgr Received | 2017-04-03 |
| Date Added to Maude | 2017-04-19 |
| 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 |
| 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 8000 C (701) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DCN |
| Date Received | 2017-04-19 |
| Model Number | C701 |
| Catalog Number | 05641489001 |
| 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 8000 C (701) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-19 |
| Model Number | C701 |
| Catalog Number | 05641489001 |
| 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 | 2017-04-19 |