MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-20 for ELECSYS INSULIN 12017547122 manufactured by Roche Diagnostics.
[68101636]
(b)(4). The customer has discarded the reagent pack in question.
Patient Sequence No: 1, Text Type: N, H10
[68101637]
The customer complained of issues with elecsys insulin quality controls (qc) since (b)(6) 2017 on a cobas 8000 e 602 module. The customer stated qc started to drift low on (b)(6) 2017 while using reagent lot 157805-01. Qc was run on (b)(6) 2017 and the results were out of range. Qc was rerun and the results were acceptable. Later that day when qc was run, the results had drifted out again. At this point, the customer pulled all of the patients that had been previously tested for insulin and repeated the samples. Out of 12 patient samples, corrected reports were issued for 5 of them. Based on the data provided for these 5 patient samples, the results for 2 patient samples were erroneous and had been reported outside of the laboratory. Patient 1 initial insulin result was 12. 86 uu/ml. The repeat result was 24. 1 uu/ml. Patient 2 ((b)(6) male) initial insulin result was 14 uu/ml. The repeat result was 30 uu/ml. The customer put a new reagent pack on the instrument of 157805-02. Qc has been fine since using the new reagent pack. The customer indicated this reagent pack was from the same shipment as the previous reagent pack. The customer thinks the issue was limited to the one reagent pack. The customer discarded the reagent pack in question. No adverse event occurred. The e602 module serial number was (b)(4). The field service engineer (fse) visited the customer site. The instrument was checked and no problems were found. The insulin results have been steady since the customer replaced the reagent pack in question. The calibration and qc data provided by the customer are within specifications. A specific root cause could not be identified. A general reagent issue was not observed since the qc data provided was within expectations. Potential root causes of the drifting qc results and the discrepant results are likely related to transportation, storage, contamination or handling issues of the insulin reagent pack with 157805-01. The issue was solved by replacing the reagent pack.
Patient Sequence No: 1, Text Type: D, B5
[69460748]
The customer stated there have not been issues with any other reagent packs. The issue only occurred with the particular reagent pack mentioned in this complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00379 |
| MDR Report Key | 6342974 |
| Date Received | 2017-02-20 |
| Date of Report | 2017-03-09 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-02-03 |
| Date Added to Maude | 2017-02-20 |
| 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 |
| 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 | 2017-02-20 |
| Model Number | NA |
| Catalog Number | 12017547122 |
| Lot Number | 15780501 |
| ID Number | NA |
| Device Expiration Date | 2017-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-02-20 |