FDA Adverse Event Injury Summary report: N

SPECTROMETER

MDR report key: 9341648 · Received November 18, 2019

Report

Report Number
MW5091162
Event Type
Injury
Date Received
November 18, 2019
Date of Event
May 14, 2014
Report Date
November 16, 2019
Manufacturer
PERKIN ELMER HEALTH SCIENCES CANADA, INC.
Product Code
ONV
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MN, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

STROKE AS RESULT OF PRODUCT. THE STATE OF (B)(6) CHANGED THE NEWBORN SCREENING PROVIDERS IN 2014, FROM (B)(6) CLINIC TO PERKIN ELMER AND WERE TOLD THEY WERE BUYING COMPARABLE SERVICE. THE PERKIN ELMER SPECTROMETER WAS REPLACED, I WAS TOLD THE EQUIPMENT WAS NOT SENSITIVE ENOUGH TO HAVE PICKED UP MY SON'S CONDITION. THE STATE OF (B)(6) PROVIDED INFO THAT SHOWED (B)(6) WOULD HAVE CAUGHT HIS CONDITION. THE STATE OF (B)(6) POCKETED THE (B)(6) THEY SAVED BY USING PERKIN ELMER AND ADJUSTED THEIR CUT OFFS WHILE MOST OF OUR INFO WAS WITHHELD AND SANITIZED. I WAS TRANSFERRED TO LAWYERS WHO CALLED THIS AN UNFORTUNATE TRAGEDY AND THEY WENT ON WITH THEIR LIVES. OUR (B)(6) OLD SON WAS SO DAMAGED HE COULDN'T EVEN MOVE OR SWALLOW. WE HAD TO MOVE TO A SUBURB THAT HAS A BETTER SERVICES FOR DISABLED STUDENTS. WE LIVE IN A RAMBLER BECAUSE IT HAS A WHEELCHAIR RAMP. HE'S IN A WHEELCHAIR, AND CAN'T WALK. PEOPLE CHASE ME AROUND (B)(6) SAYING I AM PARENTING WRONG, AND WHAT I SHOULD DO BECAUSE HE DOESN'T LOOK DIFFERENT BUT, IS PHYSICALLY DAMAGED. WE HAVE ABOUT 2 EXTRA APPTS A WEEK TO ADDRESS THE AFFECTS OF THE STROKE AND SOMETIMES AS MUCH AS 5. PLEASE CONTACT ME FOR MORE INFO (B)(6), OR (B)(6). I HAVE THE INFO, I CAN EMAIL YOU. WE FOUND OUT THAT THE TEST EQUIPMENT WAS NOT FUNCTIONING CORRECTLY, WHEN MY SON ALMOST DIED FROM SOMETHING PERKIN ELMER SHOULD HAVE CHECKED FOR. BABIES ALL OVER THE COUNTRY ARE TESTED BY THIS INFERIOR EQUIPMENT, WITH FLAT ALGORITHMS, WHICH LEAVE BABIES AT RISK. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1131061 SPECTROMETER ELECTRICAL IMPEDANCE SPECTROMETER ONV PERKIN ELMER HEALTH SCIENCES CANADA, INC.

Patients

Seq Age Sex Outcome Treatment
1 5 YR Congenital Anomaly| H| L| O| S