MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-10 for CYSTATIN C TQ GEN.2 06600239190 manufactured by Roche Diagnostics.
[79952381]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[79952382]
The customer complained of erroneous high results for 1 patient tested for cysc tina-quant cystatin c gen. 2 (cysc) on a cobas 6000 c (501) module. Erroneous results were reported outside of the laboratory to the physician who classified the results as implausible. The sample was sent to a partner laboratory for verification where the high cysc results were not reproduced. Refer to data titled "patient results" for the erroneous results and other relevant tests at the time of the event. The high cysc results were not used for diagnosis or therapy decisions. The patient was not adversely affected. The c501 module serial number was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01420 |
| MDR Report Key | 6696832 |
| Date Received | 2017-07-10 |
| Date of Report | 2017-10-23 |
| Date of Event | 2017-06-20 |
| Date Mfgr Received | 2017-06-22 |
| Date Added to Maude | 2017-07-10 |
| 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 | 0 |
| Brand Name | CYSTATIN C TQ GEN.2 |
| Generic Name | CREATININE TEST SYSTEM |
| Product Code | NDY |
| Date Received | 2017-07-10 |
| Model Number | NA |
| Catalog Number | 06600239190 |
| Lot Number | 19347701 |
| ID Number | NA |
| Device Expiration Date | 2018-06-30 |
| 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 | 2017-07-10 |