MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-03 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[4041893]
The customer received a questionable phenytoin result for one patient sample. The initial result was 31. 8 ug/ml and was reported outside the laboratory. Due to a rule set up in the customer's system, the sample was repeated and the result was 24. 0 ug/ml. The sample was set to another laboratory and was tested on a dade instrument with results of 24, 22 and 19 ug/ml. The repeat result of 24. 0 ug/ml was believed to be correct and reported out. The patient was not adversely affected. The phenytoin reagent lot number and expiration date were requested, but were not provided. The field service representative could not duplicate problem. He found all other assays were running correctly. He noted the customer was having blank cell issues at the time of the occurrence and the cells had been changed before his arrival. To verify the analyzer operation, he ran precision testing.
Patient Sequence No: 1, Text Type: D, B5
[11399377]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[20557048]
The investigation could not determine a specific root cause based on the provided data.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-07371 |
| MDR Report Key | 3497626 |
| Report Source | 05,06 |
| Date Received | 2013-12-03 |
| Date of Report | 2013-12-04 |
| Date of Event | 2013-11-13 |
| Date Mfgr Received | 2013-11-22 |
| Date Added to Maude | 2013-12-03 |
| 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 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2013-12-03 |
| Model Number | NA |
| Catalog Number | 05860636001 |
| 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 | 2013-12-03 |