MAUDE Adverse Event Report: BIOMERIEUX, S.A. VIDAS® HCG

Catalog Number 30405-01

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2017

Event Type  malfunction  

Event Description

A customer from the united states reported to biomérieux a false underestimated result for a urine sample from a (b)(6) female patient, with a possible ectopic pregnancy, in association with vidas® hcg 60 test.The customer stated the patient sample tested (b)(6) weeks ago for beta hcg.A new sample was tested with vidas® hcg on (b)(6) 2017 and the result was <2.00 mui/ml (negative).The sample was repeated neat with the same result of 2.00 mui/ml.The customer reported the same sample was diluted with male serum (<2.00 mui/ml), and with a high control (344.34 mui/ml).The customer received a hcg (b)(6) result when the sample was tested using a manual method on the urine sample.The same sample was sent to the reference lab and the result was 319 miu/ml ((b)(6)).The customer stated the controls were within expected ranges and she made sure the spur and sample were added.The customer reported the negative result was not reported to a physician as the manual method urine test and reference lab results were positive for hcg.The patient treatment was not impacted and there was no delay in reporting results.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from the united states reported to biomérieux a false underestimated result in association with vidas® hcg 60 test (udi 03573026064914).The customer did not submit the isolate for evaluation.An investigation was performed.A review of quality records confirmed the vidas® hcg lot 1004936940 met all product specifications.Six internal samples (one negative and five positive) were tested on a retained vidas® hcg kit, lot 1004936940.The results obtained for each of the six samples were within specification.The analysis of the control card for these six samples showed that vidas® hcg kit, lot 1004936940 is in the trend of the other batches.Compared to the results obtained during the release, the vidas® hcg kit, lot 1004936940 has not changed.The customer did not provide the isolate or information on the patient's clinical history, thus further evaluation is not possible.The investigation concluded the vidas® hcg kit, lot 1004936940 performed as intended.

• Brand Name: VIDAS® HCG
• Type of Device: VIDAS® HCG
• Manufacturer (Section D): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6500574
• MDR Text Key: 73247392
• Report Number: 3002769706-2017-00074
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K921302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2017
• Device Catalogue Number: 30405-01
• Device Lot Number: 1004936940
• Other Device ID Number: 03573026064914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20 YR