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 2016-03-17 for TOTAL PROTEIN URINE/CSF GEN.3 03333825190 manufactured by Roche Diagnostics.
[40596609]
Patient Sequence No: 1, Text Type: N, H10
[40596610]
The customer complained of a quality control (qc) recovery issue when the customer converted from c. F. A. S. Puc calibrator to the cfas tpuc 200 calibrator when testing total protein urine/csf gen. 3 (tpuc3). Customer support determined that the customer had not programmed the recommended special washes for the tpuc3 tests. The customer indicated that he added the special wash and re-calibrated but qc was still high. He performed a comparison study with another analyzer which did not meet his specification. During troubleshooting, the customer mentioned that the tpuc3 results for 4 patients were reported outside of the laboratory. The results for 1 patient sample were erroneous. The initial tpuc3 result was 52. 6 mg/dl. This result was reported outside of the laboratory. On (b)(6) 2016 the sample was repeated twice on a different analyzer and the results were 22. 9 mg/dl and 22. 5 mg/dl. An additional repeat test was performed (b)(6) 2016 on the original analyzer after the customer had added the special wash to tpuc3 and the result was 26. 2 mg/dl. No adverse event occurred. The c501 analyzer serial number was (b)(4). The customer declined a service visit as he does not think there is a problem with the analyzer. Qc was acceptable.
Patient Sequence No: 1, Text Type: D, B5
[51251679]
Based on the information available for investigation, a specific root cause could not be identified. There was a sudden shift to higher recoveries for qc and patient results on the day of the event. The root cause for this shift is unknown. Possible causes may be related to the reagent, a carry-over issue or a pre-analytical issue. A pre-analytical issue is the most likely root cause. A general analyzer related issue can be excluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00316 |
| MDR Report Key | 5508017 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-03-17 |
| Date of Report | 2016-08-02 |
| Date of Event | 2016-02-25 |
| Date Mfgr Received | 2016-02-26 |
| Date Added to Maude | 2016-03-17 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | TOTAL PROTEIN URINE/CSF GEN.3 |
| Generic Name | TURBIDIMETRIC, TOTAL PROTEIN |
| Product Code | JGQ |
| Date Received | 2016-03-17 |
| Model Number | NA |
| Catalog Number | 03333825190 |
| Lot Number | 62136101 |
| ID Number | NA |
| Device Expiration Date | 2017-01-31 |
| 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 | 2016-03-17 |