FDA Adverse Event Injury Summary report: N

ACCU-CHEK SPIRIT

MDR report key: 1241784 · Received November 20, 2008

Report

Report Number
2183996-2008-01759
Event Type
Injury
Date Received
November 20, 2008
Date of Event
November 3, 2008
Report Date
November 6, 2008
Manufacturer
DISETRONIC MEDICAL SYSTEMS
Product Code
LZG
PMA / PMN Number
K060876
Removal / Correction Number
NA
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
NE, US
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 1

IN 2008, THE PATIENT REPORTED HIS INSULIN INFUSION DEVICE IS MAKING AN ABNORMAL "VIBRATING" NOISE WHEN HIS BASAL RATE INSULIN IS DELIVERED. HE SAID HE HEARS AND FEELS THIS "VIBRATION" EVERY 3 MINUTES. HE STATED THE DISPLAY CONTINUES TO SHOW THE BASAL RATE FOR THAT HOUR AND HE HAS NOT RECEIVED ANY ALERTS OR ALARMS. HE SAID HE NOTICED THE NOISE ABOUT 36 HOURS AFTER THE DISCOVERED A KINKED LUER LOCK. THE PATIENT STATED THAT ON THREE DAYS PRIOR, HE WAS WORKING IN A CRAWL SPACE AT AN AWKWARD ANGLE AND HIS INFUSION SET TUBING AT THE LUER LOCK KINKED. HE SAID THE INSULIN WAS "GOING SOMEWHERE" BUT HE DID NOT RECEIVE IT AS HE EXPERIENCED ELEVATED BLOOD GLUCOSE READINGS OF 143 MG/DL AT LUNCH TIME. HE TOOK A 5.5 UNIT BOLUS OF INSULIN AND AT 6PM HIS READING WAS 257 MG/DL. HE SAID AT THIS TIME HE NOTICED THE KINKED LUER LOCK AND CHANGED HIS INFUSION SET TUBING. HE BOLUSED 4.6 UNITS OF INSULIN, ATE A MEAL, AND AT 8PM HIS READING WAS 288 MG/DL. HE BOLUSED 1.9 UNITS AND AT 11PM HIS READING WAS 256 MG/DL FOR WHICH HE BOLUSED 1.5 UNITS OF INSULIN. ON THE NEXT DAY, HE WOKE UP WITH A READING 99 MG/DL AND BY NOON, IT WAS 144 MG/DL. HE BOLUSED 4.7 UNITS OF INSULIN AND WHEN HE GOT HOME HE CHANGED HIS INSULIN CARTRIDGE AND TUBING. AT 4PM HIS READING WAS 91 AND AT 8PM, IT WAS 96 MG/DL. HE STATED HIS MORNING READING ON A DAY PRIOR TO ORIGINAL DATE, WAS 75 MG/DL WHICH IS WITHIN HIS NORMAL RANGE WHERE IT HAS REMAINED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO 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 54 YR Required Intervention INSULIN INFUSION SET| INSULIN