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 2018-06-29 for TOTAL PROTEIN URINE/CSF GEN.3 03333825190 manufactured by Roche Diagnostics.
[113003266]
Unique identifier (udi)# (b)(4). The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[113003267]
The customer complained of possible interference causing a high tpuc3 total protein urine/csf gen. 3 result for 1 patient's urine sample tested on a cobas integra 400 plus. The initial tpuc3 result was 192 mg/dl. The calculated 24 hours urine protein excretion was 3173. 0 mg/24h. On (b)(6) 2018 from a beckman coulter (colorimetric method) the calculated 24 hours urine protein excretion was 227 mg/24h. The result from the beckman coulter was considered correct and was released to the patient. Tpuc3 was also tested on a cobas c501 in another laboratory and it was stated the "c501 reproduced the result of the integra 400 plu. " no further details were provided. The erroneous result was not released outside of the laboratory. There was no allegation of an adverse event. The integra 400 plus serial number was (b)(4). It was noted that bubbles were present on the patient sample before being placed on the instrument. Control results on the day of event were acceptable. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02152 |
| MDR Report Key | 7651886 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-29 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-06-07 |
| Date Mfgr Received | 2018-06-15 |
| Date Added to Maude | 2018-06-29 |
| 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 | TOTAL PROTEIN URINE/CSF GEN.3 |
| Generic Name | TURBIDIMETRIC, TOTAL PROTEIN |
| Product Code | JGQ |
| Date Received | 2018-06-29 |
| Model Number | NA |
| Catalog Number | 03333825190 |
| Lot Number | 307921 |
| ID Number | NA |
| Device Expiration Date | 2019-04-30 |
| 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 | 2018-06-29 |