MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK; IN VITRO DIAGNOSTICS

Catalog Number 6802220

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 07/18/2014

Event Type  malfunction  

Event Description

The customer obtained discordant but reproducible vitros total b-hcg ii results from a patient sample tested undiluted and diluted (10 fold) on a vitros 5600 integrated system.Vitros b-hcg undiluted = 1644, 1651 vs.Diluted 10x = 7983, 8495 miu/ml.Ortho clinical diagnostics conservatively considers the expected vitros total b-hcg ii results for the patient sample to be the diluted values based on similar hcg results obtained using a non-vitros method.Biased results of the magnitude and direction observed may lead to inappropriate physician action if the results were to recur undetected.The vitros total b-hcg ii results were not reported from the laboratory.There was no allegation of patient harm as a result of this event.(b)(4).

Manufacturer Narrative

The investigation determined that discordant but reproducible vitros total b-hcg ii test results were obtained from a patient sample tested undiluted and diluted (10 fold) on a vitros 5600 integrated system.It is conservatively concluded that the vitros total b-hcg ii results obtained from the diluted sample are the expected hcg results based on a comparable hcg result obtained using a non-vitros method; however, this was not confirmed.There was no indication that a reagent issue contributed to the event.The root cause of this event is unknown.However, an instrument related issue or an unknown sample related event cannot be ruled out as potential contributing factors.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 4013123
• MDR Text Key: 21493158
• Report Number: 3007111389-2014-00182
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2014

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: 01/22/2015
• Device Catalogue Number: 6802220
• Device Lot Number: 1100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2014
• Initial Date FDA Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1