FDA Adverse Event Injury Summary report: N

ACCU-CHEK ® COMFORT CURVE TEST STRIPS

MDR report key: 1810335 · Received August 20, 2010

Report

Report Number: 1823260-2010-04995
Event Type: Injury
Date Received: August 20, 2010
Date of Event: August 13, 2010
Report Date: September 2, 2010
Manufacturer: ROCHE DIAGNOSTICS
Product Code: LFR
PMA / PMN Number: K010362
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: NURSE

Narratives

Description of Event or Problem · 1

IN AN ARTICLE TITLED "A COMPARATIVE ANALYSIS OF THE RESULTS OF VERTEBROPLASTY AND KYPHOPLASTY IN OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES", A PROSPECTIVE STUDY OF 28 VERTEBROPLASTY PTS AND 24 KYPHOPLASTY PTS TREATED OVER THE PAST 2 YRS WAS PRESENTED. THE FOLLOWING EVENT REPORTED: THE PT UNDERWENT A KYPHOPLASTY PROCEDURE USING A BIPEDICULAR APPROACH AT LEVEL T8. CEMENT EXTRAVASATION OCCURRED. THE CEMENT EXTRAVASATION OCCURRED INTO THE INTRADISCAL SPACE, ANTERIOR TO THE VERTEBRAL BODY, ALONG THE NERVE ROOT, AND INTO THE SPINAL CANAL. THERE WERE NO NEUROLOGICAL DEFICIT REPORTED. NO ADDITIONAL INFO WAS REPORTED.

Description of Event or Problem · 1

CALLER STATES PATIENT TESTED 100 MG/DL ON THE INFORM SYSTEM. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THIS RESULT AND LAB VALUE DRAWN WITHIN 10 MINUTES OF INFORM RESULT RETURNED AS 43 MG/DL. PATIENT WAS TREATED WITH 50% DEXTROSE BASED ON LAB VALUE. PATIENT WAS DISCHARGED FROM THE HOSPITAL 2 DAYS LATER. CALLER STATES PATIENT MAY HAVE PERIPHERAL BLOOD FLOW ISSUES. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCU-CHEK ® COMFORT CURVE TEST STRIPS	BLOOD GLUCOSE MONITORING TEST STRIPS	LFR	ROCHE DIAGNOSTICS	NA	551304

Patients

Seq	Age	Sex	Outcome	Treatment
1	054 YR		Required Intervention