MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for VIDAS? CK MB 30421 manufactured by Biomerieux Sa.
[136858753]
A customer in (b)(6) reported a falsely elevated result for an external quality control (eqa) sample in association with the vidas? Ck mb assay (lot: 1006158480). The customer reported that for cycle 8, sample 1 the result was too high. The customer stated that eqa was performed once per month and the assay was repeated with similar results. There was no patient involvement as the event pertained to a quality control sample. The customer stated other testing was then performed on different analyzers at different labs. The biom? Rieux local application specialist requested samples from two different labs to cross check but high results were obtained. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020790-2019-00007 |
| MDR Report Key | 8286105 |
| Date Received | 2019-01-29 |
| Date of Report | 2019-03-12 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2017-12-12 |
| Date Added to Maude | 2019-01-29 |
| 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 | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280, |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VIDAS? CK MB |
| Generic Name | VIDAS? CK MB |
| Product Code | JHX |
| Date Received | 2019-01-29 |
| Catalog Number | 30421 |
| Lot Number | 1006158480 |
| Device Expiration Date | 2018-11-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280, FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-29 |