MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-20 for INSULIN 12017547122 manufactured by Roche Diagnostics.
[32090406]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[32090407]
The customer received questionable results for antibody to thyroglobulin (anti-tg), antibodies to tsh receptor (anti-tshr), prolactin, insulin, and connecting peptide (c-peptide) from an analytical e module analyzer. The sample was submitted for investigation and was tested on different analyzers for the different assays. Refer to attachment to the medwatch for all patient data. This medwatch is for the insulin assay. Refer to the medwatchs with patient identifiers (b)(6) through (b)(6) for the other assays involved. Information concerning if any result was reported for the patient was requested, but was not provided. The customer did not use the roche results for clinical purposes. No adverse event was reported.
Patient Sequence No: 1, Text Type: D, B5
[50325948]
Additional sample from the patient was submitted for investigation. The investigation indicated an interfering factor to streptavidin was present in the sample. The interference of streptavidin is documented in product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04594 |
| MDR Report Key | 5239426 |
| Date Received | 2015-11-20 |
| Date of Report | 2015-11-20 |
| Date of Event | 2015-10-19 |
| Date Mfgr Received | 2015-10-26 |
| Date Added to Maude | 2015-11-20 |
| 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 | INSULIN |
| Generic Name | IMMUNOREACTIVE INSULIN TEST SYSTEM |
| Product Code | CFP |
| Date Received | 2015-11-20 |
| Model Number | NA |
| Catalog Number | 12017547122 |
| Lot Number | ASKU |
| ID Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-20 |