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 2017-10-16 for IGG-2 TINA-QUANT IGG GEN.2 03507432190 manufactured by Roche Diagnostics.
[90572620]
Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90572621]
The customer stated that they received an erroneous result for one patient sample tested for igg-2 tina-quant igg gen. 2 (igg) on a cobas 6000 c (501) module - c501. An aliquot of the sample which was processed on a cobas p 612 pre-analytics system, initially resulted as 300 mg/dl accompanied by a data flag. The sample was repeated, resulting as 565 mg/dl and this value was reported outside of the laboratory. The physician asked for a repeat of the sample since the patient had a high result of 3248 mg/dl in (b)(6) 2016. The primary tube of the sample was repeated on (b)(6) 2017, resulting as 3982 mg/dl. The repeat result was believed to be correct. The patient was not adversely affected. The c501 analyzer serial number was (b)(4). The field service engineer could not determine a cause and stated that there may have possibly been sample preparation errors. He repeated the primary tube of the sample twice and the results replicated consecutively. He checked all rinse mechanism functions and these were within specifications. After customer maintenance of the analyzer, calibration and quality controls were run and passed within specifications. He ran precision studies and these were within specifications. The system was fully operational. The patient is diagnosed with monoclonal gammopathy. The field application specialist stated that the sample may have contained an interferent to the igg assay based on the patient's diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02330 |
| MDR Report Key | 6951875 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-16 |
| Date of Report | 2017-11-02 |
| Date of Event | 2017-09-27 |
| Date Mfgr Received | 2017-10-02 |
| Date Added to Maude | 2017-10-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2017-10-16 |
| Model Number | NA |
| Catalog Number | 03507432190 |
| Lot Number | 24242601 |
| ID Number | NA |
| Device Expiration Date | 2019-02-28 |
| 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 | 2017-10-16 |