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 2015-08-20 for COBAS 6000 C501 MODULE 04745914001 manufactured by Roche Diagnostics.
[23530637]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[23530638]
The customer noticed qc results were drifting and that they received questionable high triglyceride results for an unknown number of patient samples. The issue involved three cobas c501 analyzers at the site. Refer to the medwatches with patient identifiers (b)(6) for the other analyzers. Data was only provided for one sample as an example. The initial result was 250 mg/dl and the repeat result was 40 mg/dl. All of the erroneous results were reported outside the laboratory. The physicians called and thought the results were high. The lower repeat results were believed to be correct. The patients were not adversely affected. The reagent lot number was 61450901 with an expiration date of 05/31/2016. The field service representative could not find a cause. He ran precision testing which passed within specifications. He confirmed there was no issue with the reagent shipment as qc was performed on reagent from other shipments and the results were the same. It was noted the lab water tanks and filter cartridges were changed on or about (b)(6) 2015 which may have caused or contributed to the issue.
Patient Sequence No: 1, Text Type: D, B5
[28200804]
A specific root cause could not be identified. As it was noted the issue disappeared after the account replaced the water tank, the event was likely due to water contamination.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03993 |
| MDR Report Key | 5017512 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-08-20 |
| Date of Report | 2015-10-13 |
| Date of Event | 2015-07-28 |
| Date Mfgr Received | 2015-07-29 |
| Date Added to Maude | 2015-08-20 |
| 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 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDT |
| Date Received | 2015-08-20 |
| 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 | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-08-20 |
| 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 | 2015-08-20 |