MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-03-13 for IGG-2 TINA-QUANT IGG GEN.2 03507432190 manufactured by Roche Diagnostics.
[69876811]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69876812]
The customer received questionable igg-2 tina-quant igg gen. 2 results for one patient sample from cobas 8000 c 502 module serial number (b)(4). The initial result was 9. 3 mg/dl with a data flag and was reported outside the laboratory as <30 mg/dl. The repeat result with an increased sample volume was 888. 4 mg/dl with a data flag. A second sample from the patient was tested and the result was 903 mg/dl. This result was reported outside the laboratory and was believed to be correct. The physician called and questioned the first result because he had expected the igg to be high and because the result on the second draw was reported out as the high value. The patient was not adversely affected. The customer refused a service visit and stated he did not believe there was a hardware issue.
Patient Sequence No: 1, Text Type: D, B5
[76652548]
A specific root cause could not be identified. No sample material was available for further testing. The calibration trace did not show any issues. Interference due to a gammopathy was possible but unlikely as the igm result was in the normal range at 42 mg/dl. After further investigation, no general interference was suspected. The customer said that the sample was a short draw so it was poured off into a micro cup for testing. Numerous alarms were noted that indicate an issue with appropriate sample volumes in the cups. The event may have been caused by sample mispipetting due to gel particulates. The customer confirmed they have not had any issues with other samples or applications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00549 |
| MDR Report Key | 6399309 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-13 |
| Date of Report | 2017-05-22 |
| Date of Event | 2017-02-09 |
| Date Mfgr Received | 2017-02-24 |
| Date Added to Maude | 2017-03-13 |
| 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 | IGG-2 TINA-QUANT IGG GEN.2 |
| Generic Name | IGG, ANTIGEN |
| Product Code | DEW |
| Date Received | 2017-03-13 |
| Model Number | NA |
| Catalog Number | 03507432190 |
| Lot Number | 15077701 |
| ID Number | NA |
| Device Expiration Date | 2018-02-28 |
| 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 | 2017-03-13 |