MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-07-01 for INTEGRA PHENYTOIN 200 20737879322 manufactured by Roche Diagnostics.
[2072861]
The customer received questionable phenytoin results for one patient sample when test on an integra 800 ananlyzer, serial (b)(4). The issue began in may. All repeat testing was performed on the same integra 800 analyzer. The initial phenytoin result was 36. 7 ug/ml and was reported outside the laboratory. "someone" requested the sample be rerun. The same sample was repeated using a variety of sample containers. The first repeat result was 16. 3 ug/ml. This value was reported in a corrected report. The second repeat result was 15. 8 ug/ml. The third repeat result was 16. 3 ug/ml. The final repeat result was 15. 9 ug/ml. The patient was not adversely affected by the event. The customer declined a field dispatch. She felt this was a patient specific issue, possibly related to a bubble in the sample.
Patient Sequence No: 1, Text Type: D, B5
[9197621]
.
Patient Sequence No: 1, Text Type: N, H10
[17042094]
No raw data of the discrepant sample measurement was provided; therefore a definite root cause could not be determined. An air bubble in the tube was most likely the cause. In this case the erroneous result was not reported outside the lab, thus, the patient was not adversely affected by the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-03600 |
| MDR Report Key | 2147776 |
| Report Source | 05,06 |
| Date Received | 2011-07-01 |
| Date of Report | 2011-09-15 |
| Date of Event | 2011-05-11 |
| Date Mfgr Received | 2011-06-20 |
| Date Added to Maude | 2011-07-01 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 | INTEGRA PHENYTOIN 200 |
| Generic Name | FLUORESCENCE POLARIZATION IMMUNOASSAY, DIPHENYLHYDANTOIN (FREE) |
| Product Code | MOJ |
| Date Received | 2011-07-01 |
| Model Number | NA |
| Catalog Number | 20737879322 |
| Lot Number | 62946501 |
| ID Number | NA |
| Device Expiration Date | 2011-10-31 |
| 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 | 2011-07-01 |