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 2018-11-28 for ELECSYS VITAMIN D TOTAL II 07028148190 manufactured by Roche Diagnostics.
[129193766]
Patient Sequence No: 1, Text Type: N, H10
[129193767]
The customer complained of questionable elecsys vitamin d ii assay results from a cobas 8000 e 801 module compared to a reference laboratory's cobas 8000 system. The customer provided one patient result that was a reportable malfunction. The date of the event is only an approximation as the customer stated the date was sometime in the middle of (b)(6) 2018. The initial vitamin d ii result was 33 ng/ml. The vitamin d ii result from the reference laboratory was 19 ng/ml. The erroneous result was reported outside of the laboratory. The vitamin d ii result of 19 ng/ml was deemed to be correct. There was no adverse event. The customer stated the biorad qc was trending higher. The customer also runs roche qc and which had acceptable results. The cobas e801 serial number was (b)(4). The sample was processed by a modular pre-analytical system. The field engineering specialist was unable to find the cause of the event. The customer ran both roche qc and biorad qc with acceptable results. The customer ran patient comparisons and the results were acceptable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04526 |
| MDR Report Key | 8112939 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-28 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-10-15 |
| Date Mfgr Received | 2018-11-08 |
| Date Added to Maude | 2018-11-28 |
| 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 TOTAL II |
| Generic Name | VITAMIN D TEST SYSTEM |
| Product Code | MRG |
| Date Received | 2018-11-28 |
| Model Number | NA |
| Catalog Number | 07028148190 |
| Lot Number | 32642801 |
| 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 | 2018-11-28 |