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 2015-09-24 for TRIGLYCERIDES 05171407190 manufactured by Roche Diagnostics.
[26729566]
The triglyceride reagent lot number used was 567107 or 610229. The expiration dates were requested, but were not provided. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[26729567]
The customer received questionable low triglyceride results for two samples from one patient that were not accompanied by a data flag. The samples were tested on cobas 8000 c702 analyzer serial number (b)(4). For sample "(b)(4)" a result of 1. 39 mmol/l was generated with no flag. This result was reported outside the laboratory. A therapeutic insulin infusion was discontinued prematurely due to the result. This resulted in a delay in the patient's recovery. The patient's current condition was "recovered". No adverse event was reported. The sample was repeated multiple times and the repeat result of 48. 6 mmol/l was believed to be correct. For sample "(b)(4)" a result of 1. 42 mmol/l was generated with no flag. The sample was repeated multiple times. Results of 46. 29 mmol/l and 44. 76 mmol/l were generated. Refer to the attachment to the medwatch for all results for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2015-04215 |
| MDR Report Key | 5101447 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-09-24 |
| Date of Report | 2015-09-24 |
| Date of Event | 2015-06-18 |
| Date Mfgr Received | 2015-09-04 |
| Date Added to Maude | 2015-09-24 |
| 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 |
| 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 | TRIGLYCERIDES |
| Generic Name | TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL |
| Product Code | CDT |
| Date Received | 2015-09-24 |
| Model Number | NA |
| Catalog Number | 05171407190 |
| Lot Number | NI |
| ID Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-24 |