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 2016-04-14 for CYSTATIN C TQ GEN.2 06600239190 manufactured by Roche Diagnostics.
[42768024]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[42768105]
The customer stated that there were erroneous results for one patient sample tested for tina-quant cystatin c gen. 2 (cysc) on a c501 analyzer. The erroneous cysc value was reported outside of the laboratory. The sample initially resulted as 4. 18 mg/dl and repeated as 4. 11 mg/dl when tested on the c501 analyzer. These results were reported outside of the laboratory and the physician did not believe the results. The sample was sent to another laboratory where it was tested on a beckman analyzer, resulting as 0. 77 mg/l. The patient was not adversely affected. The c501 analyzer serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[46622282]
It was determined that the patient has a "biclonale gammopathie".
Patient Sequence No: 1, Text Type: N, H10
[47897198]
A sample from the patient was provided for investigation. Immunofixation experiments performed with the patient sample showed positive findings, leading to a conclusion that the interference was caused by paraproteins. It was noted that the patient had gammopathy. Product labeling lists gammopathy as a possible interference with the assay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00433 |
| MDR Report Key | 5577940 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-14 |
| Date of Report | 2016-06-21 |
| Date of Event | 2016-03-21 |
| Date Mfgr Received | 2016-03-22 |
| Date Added to Maude | 2016-04-14 |
| 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 | CYSTATIN C TQ GEN.2 |
| Generic Name | CREATININE TEST SYSTEM |
| Product Code | NDY |
| Date Received | 2016-04-14 |
| Model Number | NA |
| Catalog Number | 06600239190 |
| Lot Number | 621803 |
| 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 | 2016-04-14 |