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 2017-10-04 for CYSTATIN C TQ GEN.2 06600239190 manufactured by Roche Diagnostics.
[88162541]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[88162542]
The customer complained of erroneous high results for 1 patient sample tested for cysc tina-quant cystatin c gen. 2 (cysc) on a cobas 8000 c 502 module. The initial cysc result from the c502 module was 5. 19 mg/l. This result was reported outside of the laboratory where the doctor complained the value was too high based on the patient? S prior results. The customer repeated the sample on the c502 module and obtained a result of 5. 48 mg/l. An aliquot of this sample was sent to an external laboratory using the siemens method and the result was 1. 06 mg/l. The patient? S creatinine and thyroid function were inconspicuous. Quality control results were acceptable. The last preventive maintenance by the field service engineer (fse) was on 11-jul-2017. There was no allegation that an adverse event occurred. The c502 module serial number was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02197 |
| MDR Report Key | 6913444 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-04 |
| Date of Report | 2017-12-04 |
| Date of Event | 2017-09-06 |
| Date Mfgr Received | 2017-09-14 |
| Date Added to Maude | 2017-10-04 |
| 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 | 2017-10-04 |
| Model Number | NA |
| Catalog Number | 06600239190 |
| Lot Number | 233285 |
| 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 | 2017-10-04 |