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 2017-05-24 for VIDAS? PROLACTIN 30410 manufactured by Biomerieux, S.a..
[75858362]
A customer from (b)(6) reported a discrepancy when correlating results between the vidas? Prolactin test kit ((b)(4)) and chemiluminescence methods. A patient serum sample was tested (b)(6) 2016 with vidas? And produced a result of 85. 53 ng/ml. Due to this result the patient started treatment with cabergoline (0. 5 mg) in (b)(6) 2016. On (b)(6) 2016 a prolactin control was performed and the result was 35. 13 ng/ml. The customer reported the next control test was (b)(6) 2017 and the result was 75. 18 ng/ml with vidas?. This same sample was then processed by chemiluminescence and the result was 0. 7 ng /ml (rv: 4. 79-23. 3). A new serum sample was tested (b)(6) 2017 with vidas? And the result was 74. 03 ng/ml. This sample was processed in two laboratories by chemiluminescence and the results were <2 ng/ml (rv: 4. 79-23. 3); and 0. 5 ng/ml (rv:1. 9-25). Another sample tested (b)(6) 2017 gave a 70. 22 ng/ml result. Patient serum samples were then tested with mini vidas? And the results of the samples were 31. 40 and 31. 86 ng/ml, respectively. The customer's monthly qcv and prolactin external quality control results were as expected. The customer stated the vidas? Results do not correlate with the clinical history of the patient. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[77899858]
A customer from colombia reported discrepant values for the vidas? Prolactin test kit when compared to the chemiluminescence method, for prolactin control samples from a patient that were tested on (b)(6) 2017. The customer did not provide a sample or test report for evaluation. An investigation was performed. A review of quality records confirmed the vidas? Prolactin test kit (lot 1005172980) met specifications. The quality product laboratory has tested a calibration sample and six internal samples on a retained vidas? Prolactin test kit (lot 1005172980). The results were: (b)(6). The results obtained for the calibration sample and six internal samples were within the specifications. The analysis of the control charts plus one additional sample of high concentration ([123. 5-199. 54] ng/ml 3is) showed that vidas? Prolactin test kit (lot 1005172980) was within the trend of the other batches. The vidas? Prolactin test kit (lot 1005172980) performed as intended. The customer did not provide a sample or information related to the other method used, thus further investigation is not possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2017-00126 |
| MDR Report Key | 6587662 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-25 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2017-05-11 |
| Device Manufacturer Date | 2016-09-23 |
| Date Added to Maude | 2017-05-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, S.A. |
| Manufacturer Street | 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 | 3 |
| Brand Name | VIDAS? PROLACTIN |
| Generic Name | VIDAS? PROLACTIN |
| Product Code | JJY |
| Date Received | 2017-05-24 |
| Catalog Number | 30410 |
| Lot Number | 1005172980 |
| ID Number | 03573026064969 |
| Device Expiration Date | 2017-09-14 |
| 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, S.A. |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-24 |