MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-06-23 for COBAS 8000 C (701) MODULE C701 manufactured by Roche Diagnostics.
[78259128]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[78259129]
The customer received questionable low valp2 valproic acid results that were reported to the doctor on (b)(6) 2017. On (b)(6) 2017, the doctor noticed that the results were low compared to the medicine dosage and requested the samples be repeated. The samples were repeated on the same cobas 8000 c (701) module with a new reagent pack of the same lot and the results were 10-20% or more higher than the initial results. Some samples were repeated on a cobas 8000 c 702 module and the results matched the repeat results. Of the data provided for 27 patient samples, only the results for seven patient samples were discrepant. Refer to the attachment to the medwatch for all patient data. There was no allegation of an adverse event. The reagent lot number was 176393. The expiration date was requested but was not provided. The qc results were in range on the morning of the event using the suspect reagent pack. It was suspect the reagent had deteriorated during the day or there was a hardware issue related to the instrument pipetting.
Patient Sequence No: 1, Text Type: D, B5
[132608753]
A specific root cause could not be determined. The customer declined a service visit as they plan to switch to a new analyzer. The customer stated in the meantime, they will monitor the situation with qc and change the reagent if needed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01313 |
| MDR Report Key | 6662864 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-23 |
| Date of Report | 2017-07-27 |
| Date of Event | 2017-06-06 |
| Date Mfgr Received | 2017-06-08 |
| Date Added to Maude | 2017-06-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| 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 C (701) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LEG |
| Date Received | 2017-06-23 |
| Model Number | C701 |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | COBAS 8000 C (701) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-23 |
| Model Number | C701 |
| Catalog Number | ASKU |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-23 |