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 2017-03-07 for COBAS 8000 C 502 MODULE C502 05964067001 manufactured by Roche Diagnostics.
[69324810]
(b)(4). The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[69324811]
The customer complained of a questionable result when testing a patient's sample for ethanol on a cobas c502 analyzer. The customer did not provide specific data. They alleged the initial ethanol was "zero," and the repeat result was an "increased value. " they also stated a breath measurement resulted as > 1 per mille. There was no allegation of an adverse event. The reagent lot number and expiration date were requested but not provided. The customer stated that after the sample needle and cuvettes were exchanged, no more errors occurred.
Patient Sequence No: 1, Text Type: D, B5
[71381234]
The erroneous result was not reported outside the laboratory. Additional data was requested for the investigation but not provided. Sample probe contamination is the typical cause for discrepant low results on this analyzer. The typical root cause for a contaminated sample probe is preanalytics. Insoluble material, such as fibrin, gel, or oil coat the probe and affect dispensing of sample into the cuvette.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00487 |
| MDR Report Key | 6384038 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-07 |
| Date of Report | 2017-03-21 |
| Date of Event | 2017-02-19 |
| Date Mfgr Received | 2017-02-20 |
| Date Added to Maude | 2017-03-07 |
| 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 | DIC |
| Date Received | 2017-03-07 |
| 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 | 2017-03-07 |
| 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 | 2017-03-07 |