FDA Adverse Event Malfunction Summary report: N

MEDTRONIC MINIMED

MDR report key: 480808 · Received August 20, 2003

Report

Report Number
MW1029378
Event Type
Malfunction
Date Received
August 20, 2003
Date of Event
May 14, 2003
Report Date
August 20, 2003
Manufacturer
MEDTRONIC MINIMED
Product Code
LZG
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
UK
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

INSULIN DEPENDENT DIABETIC, TYPE 1 SINCE 1981 UNDER NORMALLY EXCELLENT CONTROL. ON MEDTRONIC MINIMED PUMP SINCE 2000, THIS ONE SINCE 2001 AS REPLACEMENT FROM MINIMED US, LAST HBA1C APPROX 6.8 - USUALLY LOWER-. WHILST ON HOLIDAY, PUMP KEPT OUT OF SUN. BEGAN ALARMING A35 FOR NO REASON. RESOLVED BY SEALING IN SPORTGUARD AND PLACING IN COLD WATER. SELF TESTS OKAY. NO USEFUL ALARM CODE IN INSTRUCTION MANUAL, ALTHOUGH LEAD SCREW HAD NOT BEEN TOUCHED AND NOT RECENTLY AFTER NEW RESERVOIR/INFUSION SET. DID NOT TRY TO RING MINIMED AS FREQUENTLY-THEY DO NOT ANSWER EMERGENCY LINES/ SAY STATIC IS BASED ON EXPERIENCE IN PREVIOUS COUNTRIES -5TH PUMP IN 3 YEARS TO FAIL-. HAVE BEEN TOLD PREVIOUSLY ON EMERGENCY LINE THAT PERSON IS OUT SHOPPING AND NOT CONTACTABLE, OR HAVE NOT RUNG BACK, ETC, ETC. TRIED REMOVING BATTERIES AND DRAINING CAPACITOR FOR 2 HOURS. USED SPARE PUMP. RESULTED IN BLOOD SUGARS OF UP TO 350 FOR PT, KETONES, BUT RESOLVED BY CHANGING SET, MANUAL INJECTION AND BOLUSING. PUMP CONTINUED FROM THIS DATE ON AT RANDOM TO A8 ALARM. SENT LOAN PUMP BY MINIMED SO OTHER COULD BE RETURNED. PUMP ALARMED APPROX 2.3 UNITS INTO 7.5 BOLUS ON THE FIRST DAY; NO ALARM ERROR GIVEN, NO LOW BATTERY, RESERVOIR -AND UNITS INDICATOR- HAD APPROXIMATELY 198 UNITS OF INSULIN. PT CHECKED THE BASAL RATES, ALL THE SETTINGS IN SETUP I AND SETUP II AND WERE IDENTICAL TO PT CURRENT PUMP. IT WAS IN THE LEATHER ANTI STATIC CASE AND HAD BEEN SO FOR A WHILE AT THE TIME. INCREASED INTO MULTIPLE TIMES PER DAY. RETURNED TO MINIMED, NOTHING HEARD "PART" FROM IT BEING OKAY SO MUST BE MY FAULT. 2. DISPLAY FREEZING SEEMINGLY AT RANDOM, THIS OCCURRING DURING 2003 INTERMITTENTLY AT RANDOM. THIS IS NOT AS A RESULT OF BEING IN A FUNCTION, WHEN I THEN EXPECT THE DISPLAY TO BE FROZEN FOR A FEW SECONDS. THE SCREEN IS AS IT APPEARS NORMALLY IE JUST TIME, AND BASAL RATE SELECTION B IS USUAL FOR PT CURRENTLY. FREEZES FOR UP TO 10 MINUTES - MAY BE UNABLE TO STOP PUMP, OR IF CHANGING TO PRIME, OR TO BOLUS ETC, ETC. IN EVERY CASE TOLD PROBABLY STATIC THE CAUSE, DUE TO PT HAVING A LARGE STATIC FIELD AROUND PT. TOLD PUMP LIABLE FIRSTLY IN HOT WEATHER AND, THEN IN COLD DRY WEATHER. TOLD SOLUTION APART FROM WEARING PUMP IN LEATHER ANTI STATIC CASE CONSTANTLY WOULD BE TO WRAP IT IN FABRIC CONDITION SHEETS. NO CONSISTENCY IN INFO FROM MINIMED, NO DETAILED ANSWERS, NO EXPLAINATION RE: STATIC. ALSO HAD PROBLEM, WITNESSED BY OTHERS, OF BOLUSING AND NOT RECEIVING INSULIN BUT LISTED IN HISTORY. NO STATIC PROBLEMS WITH DISETRONIC SUBSEQUENTLY PURCHASED. QUALITY AND SAFETY CONCERN AND RELIABLITY AS EXPERIENCED ADVERSE DAMAGING HIGH BLOOD SUGARS DUE TO UNK CAUSE ALARMS AND COMPLETE APATHY OF MANUFACTURER, EVERYTHING BEING DUE TO STATIC AFTER THEY CAN BE PERSUADED TO LOOK AT PUMP. DUE TO EXPERIENCE ABLE TO RESPOND IN TIME TO PREVENT HOSPITALIZATION SO FAR LUCKILY, BUT INEXPERIENCED USER COULD SUFFER DKA/COMA ETC. MEDTRONIC MINIMED RETAIN THE LOAN PUMP, WHILST DISETRONIC HAS RECEIVED OLD PUMP WITH A35 ALARMS AS A TRADE IN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC MINIMED SUBCUTANEOUS INSULIN PUMP LZG MEDTRONIC MINIMED 508 *

Patients

Seq Age Sex Outcome Treatment
1 27 YR Other 1. HUMALOG INSULIN, 2. CETIRIZIN STADA-HAYFEVER| TABLETS, 3. MARVELON CONTRACEPTIVE.