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 2017-09-11 for TRIGL TRIGLYCERIDES 05171407190 manufactured by Roche Diagnostics.
[85756407]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[85756408]
The customer stated that they received an erroneous result for one patient sample tested for trigl triglycerides (trigl) on a cobas 8000 c 702 module (c702). The erroneous result was not reported outside of the laboratory. The sample initially resulted as 397 mg/dl. The sample was repeated on a second c702 analyzer, resulting as 1130 mg/dl accompanied by a data flag. The sample was repeated on the second c702 analyzer with a decreased sample volume, resulting as 3986 mg/dl. No adverse events were alleged to have occurred with the patient. According to product labeling, extremely lipemic samples can produce normal results. The customer was not using the most current version of the application parameters. In the most current test application version, the prozone check limit value was reduced in order to allow flagging of incorrect low triglyceride results of lipemic patient samples on the c702 analyzer. The customer has updated the application parameters to the most current version and have not experienced any further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01940 |
| MDR Report Key | 6854629 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-11 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-08-22 |
| Date Mfgr Received | 2017-08-22 |
| Date Added to Maude | 2017-09-11 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | TRIGL TRIGLYCERIDES |
| Generic Name | TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL |
| Product Code | CDT |
| Date Received | 2017-09-11 |
| Model Number | NA |
| Catalog Number | 05171407190 |
| Lot Number | 238467 |
| ID Number | NA |
| Device Expiration Date | 2018-05-31 |
| 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 | 2017-09-11 |