MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT1 ANALYZER, IMMUNO READY

Catalog Number	04P75-32
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Apoc incident #: (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Event or Problem Description
On (b)(6) 2022, abbott point of care (apoc) was contacted by a customer who reported that i-stat1 analyzer sn 324825 emitted smoke from battery compartment while attempting to run controls.The product was replaced at no charge.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 were being used at the time of the event.Therefore the analyzer is unlikely to become hot to touch, failing safe.The product was replaced and is being returned for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.
Additional Manufacturer Narrative
Apoc incident: (b)(4).The investigation was completed on (b)(6) 2023.The customer reported that smoke was emitted from the battery compartment of analyzer s/n (b)(6) while attempting to run controls.Failure analysis confirmed the complaint and determined the cause to be a burnt tantalum capacitor found at location c4 on the analyzer main board.A rocketware search spanning three months revealed no similar incidents and no evidence of a trend.Over the past year, the actual number of incidents caused by reliability-related failures of tantalum capacitors was (b)(4), which is less than the expected (b)(4) obtained by the reliability calculations.Therefore, no corrective or preventive action is required as the threshold has not been tripped and no product deficiency was found.Rather, this was a malfunction, which was attributed to the failure of the tantalum capacitor in the c4 location.The customer was using a battery carrier of the red (fused) configuration as a power source.The product failed-safe.There is no reason to believe that a capacitor failure while using a red carrier is likely to cause or contribute to death or serious injury.
Event or Problem Description
Na.

• Brand Name: I-STAT1 ANALYZER, IMMUNO READY
• Common Device Name: I-STAT1 ANALYZER
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): FLEXTRONICS MANUFACTURING (SINGAPORE); pte ltd; 1 kallang place; singapore 33921 1; SN 339211
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 15779424
• Report Number: 2245578-2022-00158
• Device Sequence Number: 17792434
• Product Code: CGA
• UDI-Device Identifier: 00054749003716
• UDI-Public: 00054749003716
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K001387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04P75-32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown