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

Catalog Number 6801925

Device Problem Incorrect Measurement (1383)

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

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined an unexpected (b)(6) result was obtained from a single anti-hbs (b)(6) panel sample as part of internal post expiry stability testing, using a vitros 3600 immunodiagnostic system.A definitive assignable cause could not be determined.Precision testing was not performed to verify that the instrument was operating as expected, therefore atypical instrument performance cannot be ruled out as contributing to the event.Relevant quality control data was not available, therefore the performance of the vitros ahbs reagent could also not be evaluated and a reagent issue could not be ruled out as a contributing factor.

Event Description

An ortho clinical diagnostics quality engineer became aware of unexpected (b)(6) vitros ahbs test results produced for an (b)(6) panel sample when using a vitros 3600 immunodiagnostic system.Vitros ahbs result: (b)(6) versus expected result of (b)(6).Biased results of the magnitude and direction observed may lead to inappropriate physician action.The (b)(6) vitros ahbs test result occurred on a known (b)(6) panel 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-HBS QUANTITATIVE 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: 5980834
• MDR Text Key: 56031147
• Report Number: 3007111389-2016-00183
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/29/2016
• Device Catalogue Number: 6801925
• Device Lot Number: 7540
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1