MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-09-21 for TRIGB TRIGLYCERIDES/GLYCEROL BLANKED 05976006190 manufactured by Roche Diagnostics.
[121583849]
Patient Sequence No: 1, Text Type: N, H10
[121583850]
The customer complained of low discrepant results for 3 patient samples tested for trigb triglycerides/glycerol blanked (trigb) on a cobas 8000 c 702 module. Patient 1 initial trigb result was 319 mg/dl. This result was reported outside of the laboratory where it was questioned by the doctor. On (b)(6) 2018 the sample was repeated and the result was 232 mg/dl with a data flag. The sample was repeated with auto-dilution and the result was 4121 mg/dl. On (b)(6) 2018 patient 2 (female, (b)(6)) initial trigb result was 558 mg/dl. This result was reported outside of the laboratory where it was questioned by the doctor. On (b)(6) 2018 the sample was repeated and the result was 514 mg/dl with a data flag. The sample was repeated with auto-dilution and the result was 3511 mg/dl. On (b)(6) 2018 patient 3 (female, (b)(6)) initial trigb result was 681 mg/dl. This result was reported outside of the laboratory where it was questioned by the doctor. The sample was repeated with auto-dilution and the result was 3337 mg/dl. The repeat results using auto-dilution were believed to be correct. No adverse event occurred. The c702 module serial number was (b)(4). The field service engineer (fse) visited the customer site and found the system was operating normally and there was no issue with the c702 module. The customer has not had any further events. The investigation did not identify a product problem. The cause of the event could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03233 |
| MDR Report Key | 7898155 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-21 |
| Date of Report | 2018-09-21 |
| Date of Event | 2018-08-31 |
| Date Mfgr Received | 2018-09-04 |
| Date Added to Maude | 2018-09-21 |
| 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 | TRIGB TRIGLYCERIDES/GLYCEROL BLANKED |
| Generic Name | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES |
| Product Code | CDT |
| Date Received | 2018-09-21 |
| Model Number | NA |
| Catalog Number | 05976006190 |
| Lot Number | ASKU |
| 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 | 2018-09-21 |