MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-01 for COBAS 6000 C501 MODULE 05860636001 manufactured by Roche Diagnostics.
[3755099]
The customer received a questionable phenytoin result for one patient sample. The initial result of 2. 9 ug/ml was from an aliquot of a "red top tube" processed by a client of the customer. This result was reported outside the laboratory. The doctor questioned the result and the patient was retested at the hospital with a result of 21. 9 ug/ml. An sst sample that was drawn at the same time as the original "red top tube" was tested and the results were 18. 7 ug/ml and 18. 8 ug/ml. The repeat results were believed to be correct. The customer could not provide details concerning if the patient was adversely affected. The phenytoin reagent lot number was 67251701 with an expiration date of 03/31/2014. The field service representative noted the original pour off tube was empty and discarded so it could not be checked for issues. He checked the system functions for rinse, reagent and sample dispense which were verified. He checked calibration and qc and ran precision with all results in range.
Patient Sequence No: 1, Text Type: D, B5
[11127235]
The investigation could not determine a specific root cause due to the limited information provided by the customer.
Patient Sequence No: 1, Text Type: N, H10
[11190517]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-06045 |
| MDR Report Key | 3379762 |
| Report Source | 05,06 |
| Date Received | 2013-10-01 |
| Date of Report | 2013-10-08 |
| Date of Event | 2013-09-13 |
| Date Mfgr Received | 2013-09-17 |
| Date Added to Maude | 2013-10-01 |
| 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 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 | 2013-10-01 |
| 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 | 2013-10-01 |