MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS® PROLACTIN

Catalog Number 30410

Device Problem False Positive Result (1227)

Patient Problem Misdiagnosis (2159)

Event Date 06/23/2016

Event Type  Injury  

Event Description

A customer in (b)(6) reported falsely over-estimated results with vidas® prolactin.The customer reported the results for the first test using vidas® prolactin on (b)(6) 2016, was 85.53 ng/ml.Due to this result, the patient started treatment with cabergoline in (b)(6) 2016.On (b)(6) 2016, another vidas® prolactin control test was performed and the result was 35.13 ng/ml.The next sample was tested on (b)(6) 2017, the result was 75.18 ng/ml (lot 170914).This same sample was processed by chemiluminescence and the result was 0.7 ng / ml (rv: 4.79-23.3).Due to the elevated result values, another sample was processed on (b)(6) 2017 using vidas® prolactin, the result was 74.03 ng/ml (lot 170914).That same sample was processed by chemiluminescence and the result was <2 ng / ml (rv: 4.79-23.3).In another laboratory, also by chemiluminescence, the result was 0.5 ng / ml (rv: 1.9-25).The same sample from testing performed on (b)(6) 2017 was processed again using vidas® prolactin on (b)(6) 2012, the result was 70.22 mg/ml (lot 171025).It was also processed in two other laboratories by chemiluminescence and the results were below the vidas® prolactin reference value.The customer reported that a calibration had not been performed on the test prior to processing the samples; therefore, biomerieux requested the customer calibrate the test and run the sample again.The customer did as requested and the result was 70.22 ng/ml.The patient was treated with cabergoline 0.5 mg.To ensure the patient's serum did not contain a substance that was interfering with the components of vidas® prolactin, the sample was processed on another instrument, minividas®, and the results of the sample were 31.40 ng/ml and 31.86 ng/ml.The customer reported running quality control (qcv) monthly and the results have been as expected, in addition they have an external quality control for prolactin, and the results have been as expected month to month.The results of other samples that have been processed on vidas® correlate with the patient's medical history.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) reported falsely over-estimated results with vidas® prolactin ((b)(4)).The first test result was 85.53 ng/ml, and the patient started treatment with cabergoline.The customer did not provide the isolate or alternate test method information.An investigation was performed.The complaint was investigated for discrepant values between vidas® prl lot 1005274990 (results: 70.22ng/ml) and the chemiluminescence method (results: 0.7ng/ml, <2ng/ml and 0.5ng/ml), in which the vidas® results did not fit with the clinical status.A review of quality records for vidas® prl lot 1005274990 confirmed there were no complaints or non conformities during the manufacturing process.Biomerieux tested a calibration sample and six internal isolate samples on the retained kit of vidas® prl lot 1005274990.The results were: z53 = 4.23 ng/ml 3is ( [3.32-6.34]ng/ml 3is), z56 = 2.69 ng/ml 3is ( [1.72-4.32]ng/ml 3is), z68 = 44.64 ng/ml 3is ( [39.7-55.3]ng/ml 3is), z76 = 16.4 ng/ml 3is ( [15.7-22.3]ng/ml 3is), z79 = 9.7 ng/ml 3is ( [7.88-12.1]ng/ml 3is), z88 = 99.87 ng/ml 3is ( [81.5-121]ng/ml 3is).The results obtained for the calibration and for these six 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® prl lot 1005274990 was within the trend of the other batches.In conclusion, vidas® prl lot 1005274990 performed within specifications.As the customer did not provide the isolate or alternate test method information, further investigation is not possible.

• Brand Name: VIDAS® PROLACTIN
• Type of Device: VIDAS® PROLACTIN
• Manufacturer (Section D): BIOMÉRIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• Manufacturer (Section G): BIOMÉRIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6507584
• MDR Text Key: 73262234
• Report Number: 3002769706-2017-00075
• Device Sequence Number: 1
• Product Code: JJY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2017
• Device Catalogue Number: 30410
• Device Lot Number: 1005274990
• Other Device ID Number: 03573026064969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention