FDA Adverse Event Injury Summary report: N

DIASCAN TEST STRIPS

MDR report key: 5911 · Received January 28, 1993

Report

Report Number: 33935-1992-00001
Event Type: Injury
Date Received: January 28, 1993
Date of Event: June 20, 1992
Report Date: August 17, 1992
Manufacturer: HOME DIAGNOSTICS, INC.
Product Code: CFR
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: NM, US
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

CENTER REPORTED A PATIENT HAVING VERY HIGH GLUCOSE LEVELS ADMITTED TO HOSPITAL WITH BLOOD GLUCOSE 1100MG/100ML. TEST STRIPS AT HOME INDICATED 110-120. RELEASED AFTER 3 DAYS. SAME PATIENT READMITTED WITH BLOOD GLUCOSE >1500 MG/100ML. RELEASED AFTER 5 DAYS. HAS FULLY RECOVERED.COMMENTS: EVENT DATE 6/20/92 & 7/12/92. BAXTER NOTIFIED:8/4/92 DISTRIBUTOR REPORT. HOME DIAGNOSTICS, INC., THE MANUFACTURER HAS BEEN NOTIFIED. THIS PRODUCT WAS RECALLED BY THE MANUFACTURER BECAUSE THE STRIPS COULD PROVIDE FALSELY LOW READINGSDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA, INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RECALLED BY MANUFACTURER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DIASCAN TEST STRIPS	GLUCOSE TEST STRIPS	CFR	HOME DIAGNOSTICS, INC.		DC104B

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention