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 2015-08-20 for ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 03507343190 manufactured by Roche Diagnostics.
[23863490]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[23863491]
The customer reported that they received erroneous results for one patient sample tested for tina-quant immunoglobulin a gen. 2 (iga). The sample initially resulted as 36 mg/dl on a c501 analyzer and this result was reported outside of the laboratory to the physician. On (b)(6) 2015, the customer performed electrophoresis on the sample and found a peak for iga at 61%. Refer to the attachment for the specific electrophoresis data. For the electrophoresis results, it was stated that there was "presence of two monoclonal components, one is beta- globulin, which corresponds to 26% (3. 02 g/dl) and another one is gama- globulin, which corresponds to 2% (0. 23 g/dl) from total proteins. " the result from the c501 analyzer was not consistent with the electrophoresis result or patient condition. The laboratory called the doctor and informed the doctor of the electrophoresis results. It was then decided to dilute the sample in order to check for a result that was in accordance with the electrophoresis results. The sample was diluted 1:10 and the iga result was 24 mg/dl. The sample was diluted 1:20 and the iga result was 671 mg/dl. The sample was repeated again without dilution, resulting as 23 mg/dl for iga. The sample was also repeated again with a 1:20 dilution, resulting as 840 mg/dl for iga. According to the customer, only the results obtained with the 1:20 dilution were in accordance with the electrophoresis results. The patient was not adversely affected. The c501 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[28329746]
A specific root cause could not be determined based on the provided information. A possible root cause may be related the characteristics of the patient sample. The information provided indicated the patient has myeloma. Gammopathy may be a consequence of myeloma. Product labeling states that gammopathy may cause interference with the iga assay. It was also reported that the instrument had a lot of issues related to preventive maintenance and these have since been corrected. The maintenance status of the instrument may also be a possible root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04001 |
| MDR Report Key | 5019019 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-08-20 |
| Date of Report | 2015-10-06 |
| Date of Event | 2015-07-07 |
| Date Mfgr Received | 2015-07-23 |
| Date Added to Maude | 2015-08-20 |
| 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 | ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 |
| Generic Name | IGA, ANTIGEN, ANTISERUM, CONTROL |
| Product Code | CZP |
| Date Received | 2015-08-20 |
| Model Number | NA |
| Catalog Number | 03507343190 |
| Lot Number | 178354 |
| 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 | 2015-08-20 |