MAUDE Adverse Event Report: BECTON DICKINSON & CO BD MAX SARS COV2 REAGENT; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Code Available (3191)

Event Date 06/18/2020

Event Type  Injury  

Event Description

Bd max sars - cov2 reported a positive result for this patient.The patient subsequently tested negative at the next facility.Consultation with bd and examining the curve revealed that it was most likely a false positive.If we had known the test could have rerun.The positive reaction caused the patient to need life-flight to a higher level of care.It also caused 2 patient transfers and a number of extra icu days.The pcr curve was not a curve at all and software should be able to discriminate this type of reaction and recommend repeat.Fda safety report id# (b)(4).

• Brand Name: BD MAX SARS COV2 REAGENT
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): BECTON DICKINSON & CO
• MDR Report Key: 10395816
• MDR Text Key: 202716576
• Report Number: MW5096000
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 44 YR