MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-27 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[2479043]
The customer received a questionable phenytoin result on their c501 analyzer. The patient's initial phenytoin result from a plasma sample was 20. 9 ug/ml. This result was questioned by the customer and not reported outside the laboratory. The customer repeated the test using a serum sample drawn at the same time as the initial plasma sample using another c501 analyzer, serial number (b)(4). The repeat result was 12. 9 ug/ml. The customer considered 12. 9 ug/ml to be correct because it matched the patient's previous results. There were no adverse events. The phenytoin reagent lot number was 64018901 and the expiration date was 08/31/2012. The customer declined a service visit.
Patient Sequence No: 1, Text Type: D, B5
[9608085]
It was unknown if the initial reporter sent report to the fda. The same patient samples were analyzed on two different c501 analyzers. For c501 analyzer with serial number (b)(4), refer to medwatch with (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[9896975]
.
Patient Sequence No: 1, Text Type: N, H10
[17082015]
It was determined the event was related to pre-analytical sample handling. The customer found the high result was most likely caused by the sample being drawn from an iv line and not a venipuncture. The line was most likely contaminated, causing the higher results. Results from a separate sample matched well to the previous results for this patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-01087 |
| MDR Report Key | 2469841 |
| Report Source | 05,06 |
| Date Received | 2012-02-27 |
| Date of Report | 2012-04-11 |
| Date of Event | 2012-02-13 |
| Date Mfgr Received | 2012-02-13 |
| Date Added to Maude | 2012-02-27 |
| 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 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| 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 | 2012-02-27 |
| Model Number | NA |
| Catalog Number | 05860636001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2012-02-27 |