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 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that (b)(6) results were obtained from two patient samples as part of internal stability testing, using vitros ahbs reagent with 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 quality engineer obtained two (b)(6) results from two negative panel patient samples processed as part of routine stability testing, using vitros ahbs reagent in combination with a vitros 3600 immunodiagnostic system.The (b)(6) vitros ahbs result was (b)(6) when compared to (b)(6) vitros ahbs results from repeat testing.The results obtained are as follows: (b)(6).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The (b)(6) results were obtained as part of internal stability testing and were not reported from the laboratory.There was no allegation of patient harm as a result of the events.However, it cannot be concluded that patient samples would not be affected if the events 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: 5936149
• MDR Text Key: 54757138
• Report Number: 3007111389-2016-00168
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2016
• Device Catalogue Number: 6801925
• Device Lot Number: 7530
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2016
• 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