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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT1 ANALYZER, IMMUNO READY
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ABBOTT POINT OF CARE I-STAT1 ANALYZER, IMMUNO READY Back to Search Results
Catalog Number 04P75-01
Device Problem Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/11/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2016, abbott point of care (apoc) was contacted by a customer who reported that analyzer sn (b)(4) would not power up and the battery became hot to touch.The customer states the analyzer was operating with 9v lithium batteries with a red (fused) battery carrier.The degree of heat generated by the product during the event is undetermined and purely subjective.Apoc has determined that a component failure within the analyzer circuitry, may lead to the batteries becoming uncomfortably hot to touch in the area of the battery compartment when using a green non-fused battery carrier.However, the customer states that rechargeable batteries and also a red fused battery carrier was being used.Therefore the analyzer is unlikely to become hot to touch.The product was replaced and returned for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.
 
Manufacturer Narrative
(b)(4).The investigation was completed on 05/03/2016.The customer reported that an analyzer would not power up and became hot to touch.Analyzer sn (b)(4) has not been returned to flextronics; therefore, no evaluation could be performed.There are no injuries associated with this event.Device not returned to manufacturer.
 
Event Description
Na.
 
Manufacturer Narrative
(b)(4).The investigation was completed on 12-jul-2021.The customer reported that analyzer (b)(6) would not power on and the battery carrier was hot to touch.The analyzer was returned on 19-jun-2021under a different incident (856554) because it would not activate; repair activities of analyzer s/n 376701 were performed and completed under incident 856554.Failure analysis confirmed the complaint of no activation and determined the cause to be a burnt tantalum capacitor found at location c4 on the main board.
 
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Brand Name
I-STAT1 ANALYZER, IMMUNO READY
Type of Device
I-STAT1 ANALYZER
Manufacturer (Section D)
ABBOTT POINT OF CARE
400 college road
princeton NJ 08540 6607
MDR Report Key5455637
MDR Text Key39259237
Report Number2245578-2016-00014
Device Sequence Number1
Product Code CGA
Combination Product (y/n)N
PMA/PMN Number
K001387
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04P75-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2021
Date Manufacturer Received07/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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