MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-23 for CHOLESTEROL GEN.2 03039773190 manufactured by Roche Diagnostics.
[15724209]
The cause of this event was determined to be customer handling of sample tubes. The customer was contacted reagarding proper handling of sample tues, not placing taller sample tubes into racks dedicated to be used with shorter tubes, and pouring short samples into sample cups for testing.
Patient Sequence No: 1, Text Type: N, H10
[17557836]
The user stated they were receiving questionable cholesterol results on their cobas c501 (serial number (b)(4)). The user was able to provide data for ten patients. Of that data, there was one discrepant cholesterol result reported outside the laboratory. The repeat was performed on (b)(6) 2011 and sent out on a corrected report. The patient had an initial result of 7 mg/dl the repeat result was 202 mg/dl. There were no adverse affect to the patient as a result of this event. The user declined a service visit. The user believed the problem was caused by a faulty probe that may have been partially occluded by gel. He changed the probe and there have been no further issues.
Patient Sequence No: 1, Text Type: D, B5
[17653452]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-02722 |
| MDR Report Key | 2098720 |
| Report Source | 05,06 |
| Date Received | 2011-05-23 |
| Date of Report | 2011-06-17 |
| Date of Event | 2011-04-20 |
| Date Mfgr Received | 2011-04-29 |
| Date Added to Maude | 2011-05-23 |
| 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 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 | CHOLESTEROL GEN.2 |
| Generic Name | ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL |
| Product Code | CHH |
| Date Received | 2011-05-23 |
| Model Number | NA |
| Catalog Number | 03039773190 |
| Lot Number | 63506801 |
| ID Number | NA |
| Device Expiration Date | 2011-08-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-05-23 |