MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-04 for PREA PREALBUMIN 20764655322 manufactured by Roche Diagnostics.
[89945690]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89945711]
The customer stated that they received an erroneous result for one patient sample tested for prea prealbumin (prea) on a cobas 8000 c 502 module (c502). It was asked, but it is not known if an erroneous result was reported outside of the laboratory. The sample resulted as 32 mg/dl when tested on the c502 analyzer. When the sample was tested on an olympus au480 analyzer using the n-assay tia prealbumin nittobo (made in (b)(4)), it resulted as 3. 5 mg/dl. It is unknown which value is correct. No adverse events were alleged to have occurred with the patient. The c502 analyzer serial number was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02191 |
| MDR Report Key | 6913239 |
| Date Received | 2017-10-04 |
| Date of Report | 2017-11-20 |
| Date of Event | 2017-09-13 |
| Date Mfgr Received | 2017-09-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | PREA PREALBUMIN |
| Generic Name | PREALBUMIN IMMUNOLOGICAL TEST SYSTEM |
| Product Code | JZJ |
| Date Received | 2017-10-04 |
| Model Number | NA |
| Catalog Number | 20764655322 |
| Lot Number | ASKU |
| 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 |