MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-09-14 for ANALYTICAL P MODULE 03738965001 manufactured by Roche Diagnostics.
[1709687]
The user received questionable results for phenytoin on the analytical p module on two samples collected from the same patient. The initial result for phenytoin was 0. 0 ug/ml. The sample was automatically repeated by the analyzer which gave a result of 0. 0 ug/ml. Both the initial and repeat results were accompanied by data flags. The user said per their lab policy, if a phenytoin result is < 0. 6 ug/ml, then they will report out a result of < 0. 6 ug/ml. The user reported outside the laboratory a phenytoin result of < 0. 6 ug/ml for this patient sample. The user sent an aliquot of the original patient sample to another facility for repeat analysis which yielded a phenytoin result of 25. 8 ug/ml. The method or analyzer used for repeat testing was not provided. A second sample was collected from the patient on (b)(6) 2010 which gave an initial phenytoin result of 0. 0 ng/ml. The sample was automatically repeated by the p module giving 0. 0 ng/ml. Both the initial and repeat results were accompanied by data flags. The user reported outside the laboratory a phenytoin result of < 0. 6 ug/ml for this patient sample. The user sent an aliquot of the second sample to another facility for repeat analysis on an integra analyzer. The repeat phenytoin result was 33. 1 ug/ml. No adverse event has been alleged regarding these discrepancies. The user declined a field service dispatch. User said they believed this incident to be patient sample related. The phenytoin reagent lot number was 14829200. User said patient samples are available for further investigation.
Patient Sequence No: 1, Text Type: D, B5
[8782831]
.
Patient Sequence No: 1, Text Type: N, H10
[17890584]
.
Patient Sequence No: 1, Text Type: D, B5
[17912033]
Data provided indiciated all control levels recovered acceptably. On the basis of the control recovery and investigation of the returned samples it can be concluded that the online phenytoin application is performing acceptably on the modular p analyzer. The extremely low phenytoin recoveries for the patient draws (below 0 ug/ml) are due to non-specific agglutination produced by some unknown component present in the patient sample. This interference is documented in product labeling. No adverse events in relation to the falsely low phenytoin result were reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-05430 |
| MDR Report Key | 1833996 |
| Report Source | * |
| Date Received | 2010-09-14 |
| Date of Report | 2010-12-06 |
| Date of Event | 2010-08-18 |
| Date Mfgr Received | 2010-08-26 |
| Date Added to Maude | 2010-12-06 |
| 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 ROAD |
| 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 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 |
| Product Code | DKH |
| Date Received | 2010-09-14 |
| Catalog Number | 03738965001 |
| 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 INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-14 |