MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-20 for COBAS INTEGRA 800 28122474692 manufactured by Roche Diagnostics.
[9721430]
Two syringes were provided for investigation. Teflon flaking was seen on the syringe tip, however this is not abnormal and was not responsible for the incorrect results. A problem with the syringe would have also affected the rerun result as well as other test results. No additional results were affected. A specific root cause could not be determined as the incorrect results could not be reproduced. No adverse event was reported.
Patient Sequence No: 1, Text Type: N, H10
[19910157]
The user received a questionable high phenytoin result for one patient sample that was aliquoted by the modular preanalytic analyzer. The initial result was 39. 2 ug/ml with a data flag and was called to the physician. The physician questioned the result. When the sample was repeated on the same integra 800, the result was 8. 1 ug/ml with a data flag. The result when the sample was tested on integra 800 serial number (b)(4), the result was 8. 2 ug/ml with a data flag. The 8. 1 ug/ml result was reported out. The patient was not adversely affected. The phenytoin reagent lot number was 63672801. The field service representative determined the 500ul syringes were damaged and the tips of the syringe were shaving off which was causing imprecision. The user replaced the 500ul syringes and ran precision testing to verify the analyzer operation with no issues.
Patient Sequence No: 1, Text Type: D, B5
[20042970]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-04984 |
| MDR Report Key | 2254934 |
| Report Source | 05,06 |
| Date Received | 2011-09-20 |
| Date of Report | 2012-03-29 |
| Date of Event | 2011-09-01 |
| Date Mfgr Received | 2011-09-01 |
| Date Added to Maude | 2011-09-20 |
| 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 |
| 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 INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA 800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2011-09-20 |
| Model Number | NA |
| Catalog Number | 28122474692 |
| Lot Number | NA |
| ID Number | NA |
| 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 NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-20 |