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 2018-10-05 for TRIGL TRIGLYCERIDES C701 05641489001 manufactured by Roche Diagnostics.
[123961125]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[123961126]
The customer stated that they received erroneous results for two samples from the same patient tested with triglycerides on a cobas 8000 c (701) module. The erroneous results were reported outside of the laboratory. The sick patient was at another hospital where trigl results were high (> 50 mmol/l). The patient was treated and the trigl results started to decrease. The patient was then moved to the customer site. The doctor wanted more specific results than > 50, so the lab performed a 1:10 dilution of the patient's samples. Results kept decreasing from 96 mmol/l to 81 mmol/l and then to 73 mmol/l. The customer was concerned with the complained samples since these samples initially resulted with low values which were not flagged. Samples tested after these affected samples had alarms which prompted the analyzer to automatically repeat them. The first complained sample from the patient initially resulted with a trigl value of 6. 44 mmol/l. The sample was diluted 1:10 and repeated, resulting with a trigl value of 61. 71 mmol/l. The sample was repeated without dilution, resulting with a trigl value of 3. 96 mmol/l. The sample result was corrected to > 50 mmol/l. The second complained sample from the patient initially resulted with a trigl value of 5. 25 mmol/l on (b)(6) 2018. The sample was diluted 1:5 and repeated, resulting with a trigl value of 38. 54 mmol/l on (b)(6) 2018. The sample result was corrected to 38. 54 mmol/l. No adverse events were alleged to have occurred with the patient. The trigl reagent lot number is 328103. The reagent expiration date was asked for, but not provided. Upon review of the alarm trace there were approximately 200 abnormal sample clot alarms occurring on different modules on the same line.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03449 |
| MDR Report Key | 7939502 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-05 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-09-15 |
| Date Mfgr Received | 2018-09-19 |
| Date Added to Maude | 2018-10-05 |
| 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 | 2018-10-05 |
| Model Number | C701 |
| Catalog Number | 05641489001 |
| Lot Number | 328103 |
| 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 | 2018-10-05 |