ACCU-CHEK SPIRIT

Report

Report Number: 2183996-2008-00927
Event Type: Injury
Date Received: June 20, 2008
Date of Event: June 13, 2008
Report Date: June 14, 2008
Manufacturer: DISETRONIC MEDICAL SYSTEMS
Product Code: LZG
PMA / PMN Number: K060876
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

NO PRODUCT WILL BE RETURNED FOR EVALUATION.

Description of Event or Problem · 1

IN 2008, THE PATIENT REPORTED THAT HER BLOOD GLUCOSE MEASURED 450 MG/DL THE PREVIOUS NIGHT AND SHE BOLUSED 20 UNITS OF INSULIN. THE NEXT MORNING HER BLOOD GLUCOSE WAS ELEVATED TO 598 MG/DL AND SHE BOLUSED 20 UNITS OF INSULIN. AN HOUR LATER HER BLOOD GLUCOSE MEASURED 553 MG/DL AND WHILE ON HER WAY TO WORK SHE FELT WEAK AND HAD BLURRED VISION. BY 5:00 PM HER BLOOD GLUCOSE HAD DECREASED TO 255 MG/DL AND THEN ELEVATED TO 315 LATER IN THE EVENING. SHE STATED THAT SHE HAD BOLUSED A TOTAL OF 80 UNITS OF INSULIN IN THE PAST 24 HOURS. HER NORMAL BLOOD GLUCOSE RANGE IS 100-200 MG/DL. DURING TROUBLESHOOTING THE PATIENT SAW THE LOW BATTERY SYMBOL DISPLAYED ON THE SCREEN OF THE INFUSION DEVICE. THE PATIENT USES RECHARGEABLE BATTERIES BUT HAD THE INFUSION DEVICE SET TO USE ALKALINE BATTERIES. THE PATIENT WAS INSTRUCTED TO CHANGE THE BATTERY SETTING ON THE INFUSION DEVICE AND TO INSERT A NEWLY CHARGED BATTERY. UPON FOLLOW UP ABOUT 2 DAYS LATER, THE PATIENT STATED THAT HER INFUSION DEVICE IS FUNCTIONING PROPERLY AND HER BLOOD GLUCOSE RETURNED TO NORMAL THE FOLLOWING MORNING. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCU-CHEK SPIRIT	INSULIN INFUSION PUMP	LZG	DISETRONIC MEDICAL SYSTEMS	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R	INSULIN INFUSION SET\| INSULIN