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 2018-09-04 for TG GPO-PAP 04657594190 manufactured by Roche Diagnostics.
[119669184]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[119669185]
The customer complained of discrepant results for 1 patient sample tested for trigl triglycerides (trigl) on a cobas c 111. The initial trigl result was 9. 50 mmol/l with a data flag. The sample was diluted 1:10 and repeated with a result of 3. 01 mmol/l. The sample was repeated neat and the result was 8. 97 mmol/l with no data flag. The result of 8. 97 mmol/l was reported outside of the laboratory. The sample was very lipemic so the high result was believed by the technician. On (b)(6) 2018 a new sample was obtained from the patient and the trigl result was 0. 76 mmol/l. Based on the lower result, the original sample was repeated and the result was 3. 23 mmol/l and the sample looked less lipemic. The patient was fasting when both samples were obtained. The customer is confident there was no sample mismatch. There was no allegation that an adverse event occurred. The c 111 serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02947 |
| MDR Report Key | 7841865 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-04 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-07-09 |
| Date Mfgr Received | 2018-08-14 |
| Date Added to Maude | 2018-09-04 |
| 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 | TG GPO-PAP |
| Generic Name | TRIGLYCERIDES GPO |
| Product Code | CDT |
| Date Received | 2018-09-04 |
| Model Number | NA |
| Catalog Number | 04657594190 |
| Lot Number | 31272001 |
| 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 | 2018-09-04 |