FDA Adverse Event Injury Summary report: N

ACCU-CHEK ® TENDER INFUSION SET

MDR report key: 4251517 · Received November 14, 2014

Report

Report Number: 1823260-2014-08934
Event Type: Injury
Date Received: November 14, 2014
Date of Event: September 30, 2014
Report Date: February 10, 2015
Manufacturer: ROCHE DIAGNOSTICS
Product Code: FPA
PMA / PMN Number: NA
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THIS CASE, WITH PATIENT IDENTIFIER (B)(6), AND THE CASE WITH PATIENT IDENTIFIER (B)(6) IS THE SAME EVENT, BUT REPRESENT THE TWO DIFFERENT LOT NUMBERS OF INFUSION SETS THAT WERE USED DURING THE TIME SPAN OF THE EVENT. THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT TWO OF HER INFUSION SITES. THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 698 MG/DL. SHE WAS TRANSPORTED TO THE HOSPITAL AND WAS TOLD SHE WAS "ENTERING A DIABETIC COMA". THE DOCTOR INFORMED HER THAT HER BODY WAS NOT ABSORBING INSULIN DUE TO THE INFECTION. SHE WAS TREATED WITH INSULIN AT THE HOSPITAL. SHE LATER VISITED HER DOCTOR TO DISCUSS THE INFECTION AND HE SENT HER BACK TO THE EMERGENCY ROOM. SHE HAD TWO ABSCESSES DRAINED. SHE WENT TO A FOLLOW-UP APPOINTMENT TWO DAYS LATER AND WAS URGENTLY OPERATED ON BECAUSE THE ABSCESSES HAD WORSENED. THE PATIENT REPORTED USING TWO DIFFERENT LOT NUMBERS OF INFUSION SETS DURING THE COURSE OF THIS INCIDENT. THE INFUSION SETS WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
737682	ACCU-CHEK ® TENDER INFUSION SET	SUBCUTANEOUS INFUSION SET	FPA	ROCHE DIAGNOSTICS	NA	5058511

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R