Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. INSTRUMENT MAX CLINICAL; MOLECULAR DIAGNOSTICS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON, DICKINSON & CO. INSTRUMENT MAX CLINICAL; MOLECULAR DIAGNOSTICS Back to Search Results
Model Number 441916
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Information (3190)
Event Date 07/14/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that while using the bd instrument max clinical irregular pcr curves resulting in false positive results were obtained by the laboratory personnel.Results were reported out, but it is unknown if there was any change in course of treatment.However, there was no report of patient impact.
 
Event Description
It was reported that while using the bd instrument max clinical irregular pcr curves resulting in false positive results were obtained by the laboratory personnel.Results were reported out, but it is unknown if there was any change in course of treatment.However, there was no report of patient impact.Additional information was received that the erroneous results were reported out and people were quarantined with covid positive patients.
 
Manufacturer Narrative
The following fields were updated due to additional information: b.5: it was reported that while using the bd instrument max clinical irregular pcr curves resulting in false positive results were obtained by the laboratory personnel.Results were reported out, but it is unknown if there was any change in course of treatment.However, there was no report of patient impact.Additional information was received that the erroneous results were reported out and people were quarantined with covid positive patients.H6: investigation summary: the complaint of jagged curves/ fps was reported against the bd max instrument catalog number 441916, serial number (b)(6).The customer reported spiky signal on side a, after which the readers were swapped and the issue occurred on side b.This issue was occurring on the certest sars cov-2 assay for the bd max.False positives were reported to patients and they were quarantined with covid-19 positive patients unnecessarily.The database and log files were reviewed which confirmed the issue with reader sensitivity.The customer did not follow bd's advice to check the curves for each covid test and they probably did not run a negative control on a daily basis as described in the ifu (the reader issue would have been captured with the negative control).The instrument was set aside and not used until this issue was resolved.Once the new reader was delivered, it was installed and the case was closed.The issue did not occur again on this instrument.The complaint is confirmed as an instrument issue with the information present.The investigation consisted of a review of the service notes, the instrument installation/ service history and related customer complaint data.The root cause in this case is a defective reader.The returned part was unable to be located by bd quality at the time of this investigation.No new risks, trends, or hazards were identified.
 
Event Description
It was reported that while using the bd instrument max clinical irregular pcr curves resulting in false positive results were obtained by the laboratory personnel.Results were reported out, but it is unknown if there was any change in course of treatment.However, there was no report of patient impact.Additional information was received that the errneous results were reported out and people were quarantined with covid positive patients.
 
Manufacturer Narrative
The following fields were corrected with additional information: b.1.Adverse event and/or product problem: reported issue is both an adverse event and a product problem h.1.Type of reportable event: serious injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INSTRUMENT MAX CLINICAL
Type of Device
MOLECULAR DIAGNOSTICS
Manufacturer (Section D)
BECTON, DICKINSON & CO.
7 loveton circle
sparks MD 21152
MDR Report Key10393200
MDR Text Key205318679
Report Number1119779-2020-00276
Device Sequence Number1
Product Code OOI
UDI-Device Identifier00382904419165
UDI-Public00382904419165
Combination Product (y/n)N
PMA/PMN Number
SEE H.10.
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 12/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number441916
Device Catalogue Number441916
Was Device Available for Evaluation? No
Date Manufacturer Received12/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-