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 2017-08-25 for COBAS 8000 C 502 MODULE C502 05964067001 manufactured by Roche Diagnostics.
[83686144]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[83686145]
The customer experienced an issue with analyzer alarms and questionable low results for multiple assays. The issue occurred on two cobas 8000 c 502 modules at this site. Refer to the medwatch with patient identifier (b)(6) for the other analyzer. After a reported low c-reactive protein (crp) result was questioned by a physician and a higher result was obtained upon repeat testing, the customer decided to repeat testing for about 200 samples. Of the data provided for four patient samples tested on this analyzer, only the results for three patient samples were discrepant. Refer to the attachment to the medwatch for all patient data. Information concerning if any erroneous results other than the aforementioned crp result were reported outside the laboratory was requested, but it was unknown. There was no allegation of an adverse event. The crp reagent lot number was 202456; the expiration date was not provided. The reagent lot numbers and expiration dates for the albumin and calcium reagents were requested but were not provided. The field service representative found the sample probe had descended into the gel of the sample tubes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01819 |
| MDR Report Key | 6820022 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-25 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-05-17 |
| Date Mfgr Received | 2017-05-18 |
| Date Added to Maude | 2017-08-25 |
| 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 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DCN |
| Date Received | 2017-08-25 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| 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 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-25 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| 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 | 2017-08-25 |