MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-16 for TINA-QUANT IGM GEN.2 03507041190 manufactured by Roche Diagnostics.
[40782450]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[40782451]
The customer has described that they have received questionable results for a total of 18 patient samples tested with tina-quant igm gen. 2 (igm) on a p module. With these patient samples, the customer performed a comparison between the standard application of igm and the sensitive application of igm. Both standard and sensitive applications use the same reagent and the same calibrator. It was determined that patient and control results from the sensitive application are consistently lower than results from the standard application. It was noted that both applications showed good linearity, but agreement between the two applications is poor. Of the 18 patient samples, 16 had results that were erroneous. It was asked, but it is not known if any erroneous results were reported outside of the laboratory. Refer to the attachment for the patient result data. It was asked, but it is not known if any patients were adversely affected. The p module serial number was (b)(4). Based on results from the study, the customer states that the data suggests there may be an issue with assignment of calibrator concentration for the assay.
Patient Sequence No: 1, Text Type: D, B5
[43349699]
Investigations have determined that recovery with the complained reagent and calibrator lot combination is within specifications. A specific root cause could not be determined for the issue experienced by the customer. Additional information required for the investigation was requested, but not provided.
Patient Sequence No: 1, Text Type: N, H10
[44898136]
It has been confirmed that the erroneous results were not reported outside of the laboratory and that there were no adverse events related to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00307 |
| MDR Report Key | 5504728 |
| Date Received | 2016-03-16 |
| Date of Report | 2016-05-10 |
| Date of Event | 2016-02-16 |
| Date Mfgr Received | 2016-02-17 |
| Date Added to Maude | 2016-03-16 |
| 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 | TINA-QUANT IGM GEN.2 |
| Generic Name | IGM (MU CHAIN SPECIFIC), ANTIGEN, ANTISERUM, CONTROL |
| Product Code | DAO |
| Date Received | 2016-03-16 |
| Model Number | NA |
| Catalog Number | 03507041190 |
| Lot Number | 610334 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-16 |