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 2019-05-13 for ELECSYS INSULIN 12017547122 manufactured by Roche Diagnostics.
[144953450]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[144953451]
The initial reporter stated that they received questionable results for three patient samples tested with elecsys insulin on two cobas 6000 e 601 modules (serial numbers (b)(4)). Of the three samples, one had a discrepant insulin result. It was asked, but it is not known if any incorrect values were reported outside of the laboratory. The sample initially resulted with an insulin value of 776. 1 uu/ml when tested on e 601 serial number (b)(4). The sample was repeated on e 601 serial number (b)(4), resulting with a value of 763. 9 uu/ml. The sample was tested on a competitor analyzer on (b)(6) 2019, resulting with a value of 59. 7 uu/ml. No adverse events were alleged to have occurred with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01781 |
| MDR Report Key | 8605720 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-13 |
| Date of Report | 2019-07-10 |
| Date of Event | 2019-04-12 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-05-13 |
| 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 | ELECSYS INSULIN |
| Generic Name | IMMUNOREACTIVE INSULIN TEST SYSTEM |
| Product Code | CFP |
| Date Received | 2019-05-13 |
| Model Number | INSULIN |
| Catalog Number | 12017547122 |
| Lot Number | 31572403 |
| Device Expiration Date | 2019-09-30 |
| 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 | 2019-05-13 |