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 2016-10-24 for FOLATE III 07559992190 manufactured by Roche Diagnostics.
[58200559]
(b)(4) this event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[58200560]
The customer questioned the results received for the elecsys folate iii assay from a cobas e602 analyzer. The serial number was requested but was not provided. The gastroenterologist complained to the laboratory that with the new standardization and new references values, a lot of patients are now considered to be in a clinical status of "deficiency" when they were considered to be in normal range with the previous folate assay. No specific patient data was provided. The patients were not adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[61016792]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. From the data provided, a general reagent issue was not detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01615 |
| MDR Report Key | 6050496 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-24 |
| Date of Report | 2016-11-14 |
| Date of Event | 2016-02-01 |
| Date Mfgr Received | 2016-10-06 |
| Date Added to Maude | 2016-10-24 |
| 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 | FOLATE III |
| Generic Name | ACID, FOLIC, RADIOIMMUNOASSAY |
| Product Code | CGN |
| Date Received | 2016-10-24 |
| Model Number | NA |
| Catalog Number | 07559992190 |
| 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 | 2016-10-24 |