MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-25 for VIDAS? CK MB 30421 manufactured by Biomerieux Sa.
[115367045]
A customer in (b)(6) reported to biom? Rieux falsely elevated results when testing with vidas? Ck mb (ref (b)(4)). Although product reference (b)(4) is not sold/ distributed in the united states, a similar product is (reference (b)(4)). The patient in this event was diagnosed with nste-acs one year ago. The patient has had multiple samples tested with results as follows: on (b)(6) 2017: 27. 41 ng/ml (24. 75 ng/ml repeated on vidas), on (b)(6) 2017: >300 ng/ml (>300 ng/ml repeated on vidas). Ckmb mass retested on roche cobas? : 0. 95ng/ml (0-6. 22 ng/ml ). On (b)(6) 2017: 53. 42 ng/ml (53. 93 ng/ml repeated on vidas). Ckmb mass retested on cobas: 0. 78 ng/ml (0-6. 22 ng/ml ). On (b)(6) 2018: 11. 09 ng/ml. On (b)(6) 2018: 86. 66 ng/ml. On (b)(6) 2018: 67. 79 ng/ml. Ckmb mass retested on cobas: 0. 80 ng/ml (0-6. 22 ng/ml). The physicians determined that the negative ck-mb results were more consistent with the clinical symptoms of the patient. The patient is reported as doing well and that these elevated ck-mb results had no influence on the treatment of the patient. The customer reported that patient results were not affected, both lab results were reported to the physician, no patient was harmed or treated incorrectly, and the delay in reporting results was one half to one day due to retesting the samples. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00117 |
| MDR Report Key | 7720889 |
| Date Received | 2018-07-25 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-06-23 |
| Date Mfgr Received | 2018-08-07 |
| Date Added to Maude | 2018-07-25 |
| 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 | MRS. CANDACE MARTIN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 376 CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| 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 | 2018-07-25 |
| Catalog Number | 30421 |
| 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 | 376 CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-25 |