MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-05-18 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[2709845]
The customer had been receiving questionable gentamicin results on their c501 analyzer for the past few weeks. The customer provided data for six samples, of which one had discrepant results reported outside the laboratory. All testing was performed on the same c501 analyzer. The patient's initial gentamicin result was 0 ug/ml. On (b)(6) 2012, the repeat result was 1. 02 ug/ml. The customer considered the repeat result to be correct. It was unknown if the patients were adversely affected. The gentamicin reagent lot number was 64602901 and the expiration date was 10/31/2012. The field service representative determined the sample probe had gel on the bottom of the probe. He replaced the sample probe. Calibrations and quality controls were run with results within range.
Patient Sequence No: 1, Text Type: D, B5
[9885011]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[18750873]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-02648 |
| MDR Report Key | 2580329 |
| Report Source | 05,06 |
| Date Received | 2012-05-18 |
| Date of Report | 2012-08-10 |
| Date of Event | 2012-04-28 |
| Date Mfgr Received | 2012-05-07 |
| Date Added to Maude | 2012-05-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| 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 | LCD |
| Date Received | 2012-05-18 |
| Model Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-18 |