MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-07-22 for ANALYTICAL P MODULE 03261603001 manufactured by Roche Diagnostics.
[1236221]
Customer stated he received 3 positive salicylate results on external proficiency samples which should have resulted as negative. Two of the samples were found to have discrepant results: sample 1 gave 39. 3 mg/dl, repeated (b) (6) 2009 gave 39. 6 mg/dl. Sample 2 gave 40. 9 md/dl, repeated (b) (6) 2009 gave 40. 4 mg/dl. Per survey vendor, there was no salicylate present in the challenge samples. Customer stated they did not convert the salicylate results to the correct units when reporting the survey, however, even after correction to the correct units, the results are still considered discrepant. No erroneous or discrepant pt results were generated. If additional info is received, appropriate notification will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2009-05123 |
| MDR Report Key | 1483282 |
| Report Source | 05,06 |
| Date Received | 2009-07-22 |
| Date of Report | 2009-07-22 |
| Date of Event | 2009-03-09 |
| Date Facility Aware | 2009-06-29 |
| Report Date | 2009-06-29 |
| Date Mfgr Received | 2009-06-29 |
| Date Added to Maude | 2010-04-10 |
| 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 | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | HITACHI HIGH TECH CORP |
| Manufacturer Street | 882 ICHIGE HITACHINAKA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANALYTICAL P MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER - JJE |
| Product Code | DKJ |
| Date Received | 2009-07-22 |
| Model Number | P MODULE |
| Catalog Number | 03261603001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-22 |