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 2017-11-08 for TRIGL TRIGLYCERIDES 05171407190 manufactured by Roche Diagnostics.
[92609314]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[92609315]
The customer stated that they received an erroneous results for one severely lipemic patient sample tested for trigl triglycerides (trig) on a cobas 8000 c 702 module (c702). The erroneous result was not reported outside of the laboratory. The sample initially resulted as 173. 3 mg/dl. The sample was automatically diluted 1:50 and repeated on a different analyzer, resulting as 6863. 7 mg/dl. No adverse events were alleged to have occurred with the patient. The c702 analyzer serial number was asked for, but not provided. The reaction monitor of the first result showed a strong decrease in absorbance due to oxygen depletion during the assay reaction. It was confirmed that 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. Upon review of calibration data, the last valid 2 point calibration was performed on (b)(6) 2017. From (b)(6) 2017 to (b)(6) 2017, successful blank calibrations were performed. Data was provided for one level of quality control and this was within range on the day of the event. Upon review of the alarm trace, several abnormal aspiration and sample short alarms could be observed from (b)(6) 2017 to (b)(6) 2017. The root cause is most likely related to the test application not being updated to the most current version. Based on the alarms received, a pre-analytic sample handling issue may also be a possible root cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02557 |
| MDR Report Key | 7009778 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-08 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-10-21 |
| Date Mfgr Received | 2017-10-23 |
| Date Added to Maude | 2017-11-08 |
| 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 | 2017-11-08 |
| Model Number | NA |
| Catalog Number | 05171407190 |
| Lot Number | 23846701 |
| ID Number | NA |
| Device Expiration Date | 2018-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-11-08 |