MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-20 for CORTISOL 11875116160 manufactured by Roche Diagnostics.
[2000920]
The user received questionable cortisol results for an unknown number of patient samples from the cobas e601 analyzer serial number (b)(4). Of the provided data, the results for one patient sample were discrepant and reported outside the laboratory. The initial result was >63. 44 ug/dl and the repeat result on (b)(6) 2011 was 97. 89 ug/dl. No adverse events were alleged regarding the issue. Upon evaluation of the analyzer, the field service representative determined the detection unit was damaged due to fluid. He replaced the detection unit and verified the analyzer operation by running performance testing with results within specifications.
Patient Sequence No: 1, Text Type: D, B5
[9072705]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[9249515]
The investigation determined the cause to be the leaking detection unit which was discovered by the field service representative. He found liquid had leaked on a pcb board and changed the board. The issue was solved by the replacement of the whole detection unit. No patients were affected in any way.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-02623 |
| MDR Report Key | 2098145 |
| Report Source | 05,06 |
| Date Received | 2011-05-20 |
| Date of Report | 2011-07-22 |
| Date of Event | 2011-04-24 |
| Date Mfgr Received | 2011-04-25 |
| Date Added to Maude | 2011-05-20 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA RAE ANN FARROW |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213194 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORTISOL |
| Generic Name | ENZYME IMMUNOASSAY, CORTISOL, SALIVARY |
| Product Code | NHG |
| Date Received | 2011-05-20 |
| Model Number | NA |
| Catalog Number | 11875116160 |
| Lot Number | 16130602 |
| ID Number | NA |
| Device Expiration Date | 2012-05-31 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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 | 2011-05-20 |