MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-03-07 for COBAS 8000 C502 MODULE 05964067001 manufactured by Roche Diagnostics.
[3170633]
The customer received questionable results on phenytoin (phny) on one patient sample. All results are in ug/ml. The initial result was 0. 0, accompanied by a data flag. The sample auto repeated and generated a result of 0. 0, accompanied by a data flag. The sample was repeated again generated a result of 0. 0, accompanied by a data flag. The sample auto repeated and generated a result of 0. 0, accompanied by a data flag. The customer reported the second repeat run as "none detected". The results were questioned by the physician. The sample was then repeated on the same analyzer in the sample tube and generated a result of 14. 2. The sample was then put in a roche sample cup and repeated on the same analyzer, and a result of 13. 2 was generated. The customer deemed the result of 13. 2 to be the correct result. There was no adverse event. The lot of phny reagent in use was 66737901, with an expiration date of 10/31/2013. The field service representative found the sample probe was bent and misadjusted. He replaced the probe and checked alignments. He performed precision testing, which was successful.
Patient Sequence No: 1, Text Type: D, B5
[10524854]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-01379 |
| MDR Report Key | 2993072 |
| Report Source | 05,06 |
| Date Received | 2013-03-07 |
| Date of Report | 2013-03-07 |
| Date of Event | 2013-02-14 |
| Date Mfgr Received | 2013-02-15 |
| Date Added to Maude | 2013-03-07 |
| 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 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 8000 C502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2013-03-07 |
| Model Number | NA |
| Catalog Number | 05964067001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-03-07 |