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 2018-09-19 for ELECSYS VITAMIN B12 IMMUNOASSAY 07212771190 manufactured by Roche Diagnostics.
[120833267]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[120833268]
The customer complained of discrepant results for 2 patient samples tested for elecsys vitamin b12 ii between two cobas 8000 e 602 modules. Patient 1 initial result on e602 module a was 196. 4 pg/ml. The sample was repeated on e602 module b and the result was 299. 2 pg/ml. Patient 2 initial result on e602 module a was 172. 4 pg/ml. The sample was repeated on e602 module b and the result was 271. 8 pg/ml. It is not known which result was believed to be correct. This information has been requested but has not been provided. The results were reported outside of the laboratory. There was no allegation that an adverse event occurred. The serial number for one of the e602 modules was (b)(4). The serial number for the other e602 module was not provided. The instrument had been shut down between 17-aug-2018 and 27-aug-2018 during a holiday. When staff returned, the temperature in the laboratory was between 40-50 degrees celsius. The reagents had been stored in the refrigerator between 2-8 degrees celsius, however, the customer thinks the reagents were also affected by the high heat in the laboratory. The customer changed the reagent kits and has not had any further issues. The field service engineer (fse) visited the customer site and performed maintenance and cleaned the instrument. The specific details about what was done were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03207 |
| MDR Report Key | 7890556 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-19 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-08-29 |
| Date Mfgr Received | 2018-08-31 |
| Date Added to Maude | 2018-09-19 |
| 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 B12 IMMUNOASSAY |
| Generic Name | RADIOASSAY, VITAMIN B12 |
| Product Code | CDD |
| Date Received | 2018-09-19 |
| Model Number | NA |
| Catalog Number | 07212771190 |
| Lot Number | 31974401 |
| Device Expiration Date | 2018-12-31 |
| 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 | 2018-09-19 |