MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-24 for IGM-2 TINA-QUANT IGM GEN.2 03507190190 manufactured by Roche Diagnostics.
[107099321]
Unique identifier (udi)# (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107099322]
The customer complained that the igm-2 tina-quant igm gen. 2 (igm) result from a cobas 6000 c (501) module from 1 patient sample was not correlating with the patients electrophoresis result. The igm result from the cobas c501, serial number (b)(4), was 2646 mg/dl. The result was released outside of the laboratory but the doctor did not believe the result. The customer tested the same patient sample on (b)(6) 2018 using sebia protein electrophoresis (spe) and immunofixation (ife). The spe and ife results are attached to this medwatch as attachment (b)(4). The doctor believed that with a igm result of 2646 mg/dl, that the spe gamma fraction result of 6. 7% should be higher. The customer also had the same patient sample tested at an outside laboratory on (b)(6) 2018 on a (b)(4) au with an igm result of 2582 mg/dl. The customer stated that the patient does not have waldenstrom macroglobulinemia. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
[120466271]
The investigation was unable to find a definitive root cause. As the patient had high igm results over a long period of time and high results were also obtained on a competitor's analyzer, the medications taken by the patient or the patient's diagnosis could have contributed to the issue. The correct igm result for the patient was not clear.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-01256 |
| MDR Report Key | 7453555 |
| Date Received | 2018-04-24 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-03-20 |
| Date Mfgr Received | 2018-03-26 |
| Date Added to Maude | 2018-04-24 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | 0 |
| Brand Name | IGM-2 TINA-QUANT IGM GEN.2 |
| Generic Name | IGM (MU CHAIN SPECIFIC) |
| Product Code | DAO |
| Date Received | 2018-04-24 |
| Model Number | NA |
| Catalog Number | 03507190190 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-24 |