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 2018-07-20 for ELECSYS INSULIN 07027559190 manufactured by Roche Diagnostics.
[114817470]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[114817471]
The customer questioned high results for 2 samples drawn on (b)(6) 2018 from 1 patient tested for elecsys insulin (insulin) on a cobas e 801 module. The customer suspects an interference in the patient sample as the results don't correspond to patient's clinical picture. The first sample was obtained after 4 hours fasting and had an initial insulin result of 97. 1 uu/ml. The 2nd sample was obtained after 16 hours fasting and had an insulin result of 87. 4 uu/ml. The high insulin results were reported outside of the laboratory. There was no allegation that an adverse event occurred. The e801 module serial number was (b)(4). On (b)(6) 2018 the customer performed interference testing on the 2 samples: after scantibodies hbt treatment, the insulin results were 92. 7 uu/ml for the 1st sample and 86. 6 uu/ml for the 2nd sample. The 2 samples were also treated and underwent polyethylene glycol (peg) testing where the insulin result for the 1st sample was 4. 03 uu/ml (calculated result of 16. 12 uu/ml) and the insulin result for the 2nd sample was 3. 30 uu/ml (calculated result of 13. 2 uu/ml). Both samples were submitted for investigation and tested on an e 801 module with insulin reagent lot number 269698. The insulin result from the 1st sample was 104 uu/ml and the insulin result from the 2nd sample was 94. 3 uu/ml. The customer's results were reproduced. Investigations are ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02411 |
| MDR Report Key | 7706083 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-20 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-06-26 |
| Date Mfgr Received | 2018-07-05 |
| Date Added to Maude | 2018-07-20 |
| 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 | 2018-07-20 |
| 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 | 2018-07-20 |