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 2018-12-05 for VIDAS? BRAHMS PROCALCITONIN 30450 manufactured by Biomerieux Sa.
[130061252]
A customer in (b)(6) reported a falsely underestimated result in association with the vidas? Brahms procalcitonin assay. The customer stated the initial test did not give the correct result based on the background reading, rfv, and patient condition, and that the repeat test was consistent with the patient's critical condition with sepsis. The patient had a positive blood culture on (b)(6) 2018, and pct was run on (b)(6) 2018. The customer mentioned they found a stuck solid phase receptacles (spr? ) at the end of the initial run. Position a1 - initial test: background reading : 23, sample rfv: -9, result (ng/ml): < 0. 05. Position b1 - repeat test: background reading : 169, sample rfv: 763, result (ng/ml): 15. 12. The customer reported that there was no impact to patient treatment as the repeat result which was consistent with the blood culture positive result, was reported to the physician. It was reported that the patient condition improved and they were discharged. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00250 |
| MDR Report Key | 8133944 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-05 |
| Date of Report | 2019-02-13 |
| Date of Event | 2018-09-04 |
| Date Mfgr Received | 2019-01-15 |
| Device Manufacturer Date | 2018-04-05 |
| Date Added to Maude | 2018-12-05 |
| 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 | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| 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 | 3 |
| Brand Name | VIDAS? BRAHMS PROCALCITONIN |
| Generic Name | VIDAS? BRAHMS PCT |
| Product Code | PRI |
| Date Received | 2018-12-05 |
| Catalog Number | 30450 |
| Lot Number | 1006397040 |
| Device Expiration Date | 2019-03-21 |
| 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 | 2018-12-05 |