FDA.reportPublic FDA data

MAUDE MDR 4961737

MDR report key
4961737
Report number
2245578-2015-00041
Event key
0
Event type
3
Date of event
2015-07-23
Date received
2015-08-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LINDA MACZUSZENKO
Address
400 COLLEGE ROAD PRINCETON NJ 08540 US
Phone
613-613-6136
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1I-STAT DOWNLOADER RECHARGERDOWNLOADER/RECHARGERABBOTT POINT OF CAREJBPNA04P73-04NAY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-08-030

Event Narratives#

N

Patient 1

(B)(4)

D

Patient 1

ON (B)(6) 2015, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING AN ANALYZER THAT GENERATED QUALITY CHECK CODE 86 AND BECAME HOT TO THE TOUCH WHILE CHARGING IN THE ANALYZER WHEN PLACED IN THE DOWNLOADER/RECHARGER (DRC). THE CUSTOMER STATES THAT THE RECHARGEABLE BATTERY IS NEW AND THE ANALYZER WAS JUST REPLACED ONE MONTH AGO. THE ISSUE OCCURRED ON THE SECOND DAY WHILE IN USE IN THE PATIENT TESTING AREA. ON THE MORNING (B)(6) 2015 THE ANALYZER WAS IN THE SAME DOWNLOADER, UNPLUGGED AND CODE 86 GENERATED AGAIN. HOWEVER, AT PRESENT, CODE 86 IS NO LONGER DISPLAYED. THE ELECTRONIC SIMULATOR WAS RUN ON (B)(6) 2015 AND PASSED. THE CUSTOMER WAS ASKED TO RETURN THE ANALYZER AND DRC ALONG WITH ITS ASSOCIATED RECHARGEABLE BATTERY PACK FOR INVESTIGATION. THE CUSTOMER REFUSED TO RETURN THE ANALYZER AND STATES THE ANALYZER IS FUNCTIONING AS INTENDED. THE CUSTOMER SUSPECTS THAT THE DOWNLOADER CAUSED THE EVENT AND OPTED TO RETURN DOWNLOADER AND CABLES FOR INVESTIGATION. THE PRODUCT WAS REPLACED AT NO CHARGE. PER I-STAT SYSTEM MANUAL: ART: 714368-00K, REV. DATE: 02-AUG-12: THE DOWNLOADER/RECHARGER CAN RECHARGE A RECHARGEABLE BATTERY IN THE ANALYZER. IF THE ANALYZER CONTAINS A RECHARGEABLE BATTERY, THE BATTERY BEGINS RECHARGING AUTOMATICALLY AS SOON AS THE ANALYZER IS PLACED IN THE DOWNLOADER/RECHARGER. THE DOWNLOADER/RECHARGER ALSO HAS A COMPARTMENT FOR RECHARGING A RECHARGEABLE BATTERY OUTSIDE THE ANALYZER. PLACING AN ANALYZER IN A DOWNLOADER/RECHARGER WILL AUTOMATICALLY INITIATE RECHARGING OF THE RECHARGEABLE BATTERY. THE INDICATOR LIGHT ON TOP OF THE DOWNLOADER/RECHARGER WILL BE GREEN (TRICKLE CHARGE), RED (FAST CHARGE), OR BLINKING RED (FAST CHARGE PENDING) WHEN AN ANALYZER WITH A RECHARGEABLE BATTERY IS PLACED IN THE DOWNLOADER/RECHARGER. AS WELL, PLACING A RECHARGEABLE BATTERY INTO THE RECHARGING COMPARTMENT WILL AUTOMATICALLY INITIATE TRICKLE RECHARGING. THE INDICATOR LIGHT NEAR THE RECHARGING COMPARTMENT WILL BE GREEN WHEN A RECHARGEABLE BATTERY IS PLACED IN THE COMPARTMENT. ART: 714260-00S, REV. DATE: 12-FEB-15: CODE 86 CAN OCCUR WHEN AN I-STAT ANALYZER IS STORED IN AN I-STAT DOWNLOADER/RECHARGER WITHOUT ADEQUATE VENTILATION. THIS PROBLEM CAN USUALLY BE RESOLVED BY MOVING THE DOWNLOADER/RECHARGER TO AN OPEN LOCATION WHICH IS FREE OF OBSTRUCTIONS AND EXTERNAL HEAT SOURCES SUCH AS HEATER VENTS OR OTHER ELECTRONIC EQUIPMENT. IF THIS CODE PERSISTS, OR IF CODE 86 OCCURS WITH THE PORTABLE CLINICAL ANALYZER OR I-STAT 1 ANALYZER WITHOUT A DOWNLOADER/RECHARGER, CONTACT I-STAT TECHNICAL SERVICES OR YOUR LOCAL SUPPORT ORGANIZATION FOR FURTHER ASSISTANCE. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO EVIDENCE OF A CONFIRMED MALFUNCTION AND PRODUCT WAS REPLACED AT NO CHARGE.

N

Patient 1

(B)(4). THE INVESTIGATION WAS COMPLETED ON 10/22/2015. THE CAUSE OF THE CUSTOMER COMPLAINT WAS DUE TO AN ELECTRONIC COMPONENT FAILURE.

D

Patient 1

NA