MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-12-23 for COBAS 8000 C502 MODULE 05964067001 manufactured by Roche Diagnostics.
[34275977]
Na
Patient Sequence No: 1, Text Type: N, H10
[34275978]
The customer experienced an issue with imprecision for immunoglobulin a (iga), immunoglobulin g (igg), and immunoglobulin m (igm) since (b)(6) 2015. The customer pulled random samples and repeated them on another cobas c502 analyzer. Of the data provided for two patient samples, only the igm results for one patient sample were discrepant and reported outside the laboratory. Igm initial result was 411 mg/dl and was reported outside the laboratory. The repeat result on another cobas c502 analyzer was 66 mg/dl. The repeat result on the original analyzer was 58 mg/dl. This result was believed to be correct and an amended report was issued. There was no adverse event to the customer's knowledge. The reagent lot number was 61403601 with an expiration date of 02/28/2017. The field service representative replaced valves and the customer ran calibration and qc with results within the specified limit.
Patient Sequence No: 1, Text Type: D, B5
[42220600]
Based on the provided analyzer alarm trace, it was determined there was a problem with abnormal aspiration of the sample probe. This issue was resolved by the replacement of the valve during the service visit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-06114 |
| MDR Report Key | 5322583 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-12-23 |
| Date of Report | 2016-04-07 |
| Date of Event | 2015-12-08 |
| Date Mfgr Received | 2015-12-11 |
| Date Added to Maude | 2015-12-23 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 C502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFQ |
| Date Received | 2015-12-23 |
| Model Number | NA |
| Catalog Number | 05964067001 |
| 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 C502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-12-23 |
| Model Number | NA |
| Catalog Number | 05964067001 |
| 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 | 2015-12-23 |