MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® D DIMER EXCLUSION II

Catalog Number 30455

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of falsely under-estimated result associated with vidas® d dimer exclusion ii (reference 30455).The customer indicated the test was repeated multiple times with results 1254.70 and 1421.45ng/ml.The customer reported there was no harm to the patient or erroneous treatment; however, the incorrect result was not reported to the physician.The customer indicated there was a two (2) hour delay in obtaining results.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in (b)(4) notified biomérieux of falsely under-estimated result associated with vidas® d dimer exclusion ii.An internal biomérieux investigation was performed.Vidas® d-dimer results not conform to the clinical status of the patient were found in positions d1 and e1.These results could be explained by a customer manipulation error, a reagent issue or an instrument issue.- a new d-dimer result, obtained the same day in e1 position of the instrument, was conform to the clinical status of the same patient.This result shows that the probability to have an instrument issue in e1 position is very low as nothing has been done on the system between each test.- qcv test results performed by the customer on (b)(6) 2016 and then by field service engineer (fse) on (b)(6) 2016 were conform in all positions of the instrument.- leak test results performed during the preventive maintenance by the fse in (b)(6) 2016 were conform in all positions of the instrument these results show that the probability to have an instrument issue in d1 and e1 positions is very low.Investigation at reagent level: - the customer's issue was not reproduced on the biomérieux pv kit and the customer return kit vidas dex ii lot 1005070940 / 170729-0 using an internal sample with a similar concentration.Unfortunately, the customer's sample was not available.- the kit vidas dex ii lot 1005070940 / 170729-0 is still in the current performance expectations.In conclusion, investigation did not reveal an instrument issue or a reagent issue in d1 and e1 positions.Main probable root cause could be a customer manipulation error during pre-analytics steps (missing sample, missing spr, inadequate spr or strip not correctly inserted).The customer indicated that after the fse intervention on (b)(6) 2016, they no longer obtained unexpected results.

• Brand Name: VIDAS® D DIMER EXCLUSION II
• Type of Device: VIDAS® D DIMER EXCLUSION II
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042
• MDR Report Key: 6215921
• MDR Text Key: 63654037
• Report Number: 3002769706-2016-00537
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K112818
• 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: 04/20/2017

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: 07/29/2017
• Device Catalogue Number: 30455
• Device Lot Number: 1005070940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1