MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-02-16 for VIDAS BRAHMS PROCALCITONIN 60T 30450 manufactured by Biom?rieux Sa.
[5440544]
On (b)(6) 2015, a customer contacted biom? Rieux france subsidiary to report a false positive result obtained with vidas? Brahms procalcitonin (pct) ref. 30450 lot 1003549050 (expiration date 22-oct-2015). The patient was tested (b)(6) 2014 with vidas? Brahms pct, lot 1003549050. The result was positive at 15. 63 ng/ml indicating a high risk of severe sepsis and/or septic shock. Based on the sample result and patient's clinical status, the clinician performed a lumbar puncture to confirm or exclude meningitis infection. In conjunction with the lumbar puncture procedure, the clinician collected another sample (collected at 1:00pm) for testing; the result of this test was negative at 0. 28 ng/ml. A second aliquot of the first sample was retested with vidas brahms pct and the result was negative (0. 36 and 0. 34 ng/ml). No further information has been provided regarding the clinical status of the patient or the reason to take the decision of performing the lumbar puncture. Internal biom? Rieux investigation has been initiated. As the sample for which the false positive result was reported is no longer available, the investigation will include a review of the batch file and complaint history records. This file will be updated as further information becomes available.
Patient Sequence No: 1, Text Type: D, B5
[12859010]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[33627924]
Review of the batch record confirmed no abnormalities were associated with vidas pct lot 1003549050. Review of complaint records reveals one customer complaint against the associated lot. There have been no corrective and preventive action (capa) files initiated against vidas pct assay. There have been no non-conforming material reports (ncmr) initiated against vidas pct assay. There is no evidence of non-conformity or manufacturing test failure associated with vidas pct lot 1003549050. The root cause of the customer's initial false-high pct result cannot be determined (neither the device nor the patient sample was submitted for evaluation).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00002 |
| MDR Report Key | 4518586 |
| Report Source | 01,05,06 |
| Date Received | 2015-02-16 |
| Date of Report | 2015-02-06 |
| Date of Event | 2015-02-05 |
| Date Mfgr Received | 2015-02-06 |
| Device Manufacturer Date | 2014-11-12 |
| Date Added to Maude | 2015-03-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 376, CHEMIN DE L'ORME |
| Manufacturer City | MARCY L' ETOILE, FR 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS BRAHMS PROCALCITONIN 60T |
| Generic Name | VIDAS BRAHMS PCT |
| Product Code | NTM |
| Date Received | 2015-02-16 |
| Catalog Number | 30450 |
| Lot Number | 1003549050 |
| Device Expiration Date | 2015-10-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 376, CHEMIN DE L'ORME MARCY L'ETOILE, FR 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-16 |