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 2018-09-21 for ELECSYS INSULIN 07027559190 manufactured by Roche Diagnostics.
[121462083]
This event occurred in (b)(6). The expiration date was july 2018. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[121462084]
The customer stated that they received erroneous results for two samples from the same patient tested with elecsys insulin on a cobas 8000 e 801 module. It was asked, but it is not known if the erroneous results were reported outside of the laboratory. The first sample initially resulted with an insulin value of 53. 2 uu/ml when tested on the e 801 analyzer. The sample was repeated on the e 801 analyzer on (b)(4) 2018, resulting with an insulin value of 49. 9 uu/ml. The second sample resulted with an insulin value of 49. 6 uu/ml when tested on the e 801 analyzer. The samples were sent to other laboratories for testing on siemens centaur analyzers, resulting with values of 7. 8 uu/ml and 7. 6 uu/ml. It is not known which of the two samples each of the two repeat values correspond to. No adverse events were alleged to have occurred with the patient. The e 801 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03225 |
| MDR Report Key | 7897525 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-21 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-08-22 |
| 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 | ELECSYS INSULIN |
| Generic Name | IMMUNOREACTIVE INSULIN TEST SYSTEM |
| Product Code | CFP |
| Date Received | 2018-09-21 |
| Model Number | NA |
| Catalog Number | 07027559190 |
| Lot Number | 269698 |
| Device Expiration Date | 2019-02-28 |
| 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 | 2018-09-21 |