MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-28 for TRIGL TRIGLYCERIDES 05171407190 manufactured by Roche Diagnostics.
[84000275]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[84000276]
The customer stated that they received erroneous results for two patient samples tested for triglycerides (trig) on a cobas 8000 c 702 module (c702). On (b)(6) 2017, the customer stated that both samples were tested within the past month, but could not provide details on exactly when they were tested. The date of event is not known. Both samples initially resulted with values that were approximately 240 mg/dl and these results were reported outside of the laboratory. The samples were diluted and repeated, with each resulting as approximately 4000 mg/dl. The patients were not adversely affected. The c702 analyzer serial (b)(4). When the customer's trig application settings were checked in the system software, it was determined that they were not using the current prozone limit settings for the trig application. The customer's trig prozone limit settings were updated and the test was re-calibrated.
Patient Sequence No: 1, Text Type: D, B5
[119832446]
The customer has had no further issues since updating the application settings. The event was caused by user error as the customer did not update their application setting per product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01835 |
| MDR Report Key | 6824858 |
| Date Received | 2017-08-28 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-07-09 |
| Date Mfgr Received | 2017-08-09 |
| Date Added to Maude | 2017-08-28 |
| 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 | 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 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRIGL TRIGLYCERIDES |
| Generic Name | TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL |
| Product Code | CDT |
| Date Received | 2017-08-28 |
| Model Number | NA |
| Catalog Number | 05171407190 |
| Lot Number | ASKU |
| 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 | 2017-08-28 |