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 2019-02-08 for ELECSYS VITAMIN D ASSAY 05894913190 manufactured by Roche Diagnostics.
[135719862]
The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[135719863]
The customer complained of questionable elecsys vitamin d ii assay results for 6 patients tested on a cobas 8000 e 602 module. From the data provided, 4 patient results were reportable malfunctions. For patient 1 the initial vitamin d result was >175 ng/ml with a repeat result of 42 ng/ml. For patient 2 on (b)(6) 2019, the initial vitamin d result was >175 ng/ml with a repeat result of 89. 88 ng/ml. For patient 3 on (b)(6) 2019, the initial vitamin d result was >175 ng/ml with a repeat result of 50 ng/ml. For patient 4 on (b)(6) 2019, the initial vitamin d result was >175 ng/ml with a repeat result of 58 ng/ml. The erroneous results were reported outside of the laboratory. There was no allegation of an adverse event. The cobas e602 serial number was (b)(4). Based on the acceptable qc data, there was no indication of a performance issue with the reagent or the instrument. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00523 |
| MDR Report Key | 8320293 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-02-08 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-01-07 |
| Date Mfgr Received | 2019-01-25 |
| Date Added to Maude | 2019-02-08 |
| 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 | 3 |
| Brand Name | ELECSYS VITAMIN D ASSAY |
| Generic Name | VITAMIN D TEST SYSTEM |
| Product Code | MRG |
| Date Received | 2019-02-08 |
| Model Number | NA |
| Catalog Number | 05894913190 |
| Lot Number | 36669600 |
| 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 | 2019-02-08 |