FDA Adverse Event Malfunction Summary report: N

QBC AUTOREAD PLUS

MDR report key: 130976 · Received November 5, 1997

Report

Report Number
MW4002036
Event Type
Malfunction
Date Received
November 5, 1997
Report Date
October 14, 1997
Manufacturer
BECTON DICKINSON & CO
Product Code
GHK
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
SC, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

RPTR STATES: THERE ARE SERIOUS DESIGN FLAWS IN THE CENTRIFUGE FOR THE CAPILLARY TUBES (QBC CENTRIFUGE): 1) THE INSTRUMENT IS DESIGNED TO OPERATE WITHOUT THE PROTECTIVE COVER IN PLACE. THIS CAN LEAD TO SPILLAGE OF BLOOD INTO THE CENTRIFUGE AND IT CAN NEVER BE ADEQUATELY CLEANED. FUTHERMORE THE CAPILLARY TUBE CONTAINING BLOOD IS SPLINTERED INTO SHARP PIECES WHICH CAN HURT SOMEBODY TRYING TO CLEAN THE CENTRIFUGE. 2) THE CENTRIFUGE IS VERY NOISY AND DOES NOT PERMIT ANY OTHER ACTIVITY IN THE OFFICE WHILE IT IS ON. THESE FLAWS SHOULD BE CORRECTED. RPTR'S SURPRISED THAT SUCH A POOR QUALITY PRODUCT HAS BEEN LET OUT OF CO'S DESIGN LABS! RPTR WOULD RECOMMEND THAT CO DESIGN THE CENTRIFUGE WITH <60DB NOISE LEVEL AND ALSO PREVENT THE SWITCHING ON OF THE MACHINE UNLESS THE COVERPLATE IS SECURELY SCREWED IN. CO COULD DO THIS WITH A MICROSWITCH ACTIVATED BY THE KNOB OF THE COVERPLATE (IE., IF THE COVERPLATE IS NOT SCREWED ON, THE CENTRIFUGE SHOULD NOT WORK). WHILE CO COULD POSSIBLY GET BY WITH EXPLANATIONS SUCH AS "YOU MUST READ THE INSTRUCTIONS BEFORE USE," ETC, RPTR FEELS, WHEN DEALING WITH HUMAN BLOOD, ONE MUST TAKE CARE TO BUILD IN REDUNDANCY INTO DESIGN, TO ELIMINATE SERIOUS CONTAMINATION AND RISK OF INJURY TO PERSONNEL. RPTR IS SURPRISED THAT THE FDA APPROVED THIS DEVICE. RPTR HAS AT LEAST TWO MESSAGES ON THE TECH SUPPORT LINE AND NO ONE HAS CALLED BACK. RPTR WOULD LIKE TO RETURN THE INSTRUMENT FOR FULL REFUND, UNLESS THESE PROBLEMS ARE PROMPTLY FIXED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 QBC AUTOREAD PLUS CENTRIFUGE GHK BECTON DICKINSON & CO UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 NA