MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT PACK; IN-VITRO DIAGNOSTIC

Catalog Number 6801812

Device Problem False Negative Result (1225)

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

Event Date 08/08/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined an (b)(6) anti-hav igm result was obtained from a quality control sample as part of internal post expiry stability testing, using a vitros eci immunodiagnostic system.A definitive assignable cause could not be determined.Repeat testing using the same in-house quality control material and reagent lot fell within the expected release limits.It is not known whether the vitros systems were operating as expected at the time of the events as no performance testing was undertaken.

Event Description

An ortho clinical diagnostics quality engineer became aware of (b)(6) vitros havm test results produced for an (b)(6) quality control sample when using a vitros eci immunodiagnostic system.Vitros anti-hav igm lot 4720 sample result (b)(6).Biased results of the magnitude and direction observed may lead to inappropriate physician action.The (b)(6) vitros havm test result occurred on a known (b)(6) quality control sample used for internal testing and there is no report of affected patient samples.No allegation of patient harm was made as a result of the event.However, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected in a clinical setting.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 6844403
• MDR Text Key: 86584296
• Report Number: 3007111389-2017-00134
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2017
• Device Catalogue Number: 6801812
• Device Lot Number: 4720
• Other Device ID Number: 10758750001415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1