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.
[83749884]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[83749885]
The customer noticed many low results for one patient sample and repeated it on another cobas 8000 c 502 module at the site with higher results. The customer inspected the sample probe and found traces of gel from the sample tubes on it. The customer continued running on the analyzer until the next day when they changed the sample probe. Of the data provided for two patient samples tested on this analyzer, only the results for one patient sample were discrepant. Refer to the attachment to the medwatch for all patient data. Information concerning if any erroneous results were reported outside the laboratory was requested, but it was unknown. There was no allegation of an adverse event. The albumin reagent lot number was 241675 and the calcium reagent lot number was 223264. The expiration dates were requested but were not provided. 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01820 |
| MDR Report Key | 6820016 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-25 |
| Date of Report | 2017-08-25 |
| 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 | CJW |
| Date Received | 2017-08-25 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 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 |