MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-12-16 for COBAS 6000 C501 MODULE 04745914001 manufactured by Roche Diagnostics.
[3997221]
The customer alleged they received a questionable phenytoin result on their c501 analyzer for one patient. The units of measure were requested but not provided. The patient's initial phenytoin result was 0. 0 accompanied by a data flag. The repeat result was 24. 7 accompanied by a data flag. Information on whether either result was reported outside the laboratory was requested but not provided. Information on whether the patient was adversely affected was requested but not provided. The phenytoin reagent lot number was 681554. The expiration date was requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
[11433975]
A definitive root cause could not be determined with the information provided. Additional details were requested but not provided. The reaction monitors provided for investigation indicate a possible proe- analytical issue as no sample was pipetted.
Patient Sequence No: 1, Text Type: N, H10
[11505189]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-07650 |
| MDR Report Key | 3520654 |
| Report Source | 01,05,06 |
| Date Received | 2013-12-16 |
| Date of Report | 2014-01-10 |
| Date of Event | 2013-11-23 |
| Date Mfgr Received | 2013-11-25 |
| Date Added to Maude | 2013-12-16 |
| 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 | 2013-12-16 |
| Model Number | NA |
| Catalog Number | 04745914001 |
| 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 | 2013-12-16 |