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

Catalog Number	04P75-01
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Abbott point of care (apoc) was contacted by a customer who reported that i-stat1 analyzer sn (b)(6) would not activate, and batteries are becoming hot.There was a spark and smell was observed.The customer also stated using 9v alkaline dura cell batteries which are not recommended.Customer advised by ts to use 9v lithium disposable batteries or 9v nimh rechargeable batteries with the i-stat.There was no smoke associated with the event.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 a red fused carrier was being used with 9v alkaline batters 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).Apoc labeling will be evaluated during the investigation as pertaining to the event.
Additional Manufacturer Narrative
Apoc incident: (b)(4).The investigation was completed on 12-sep-2023.The customer reported that analyzer s/n 315510 would not activate, and the batteries become hot.There was also a spark observed and a smell noted, and the battery carrier was damaged.Customer also reported using 9-volt alkaline dura cell batteries with red carrier at the time of the event.Failure analysis confirmed the complaint, and the cause was attributed to the failure of the capacitor c26 on the main pcb.Per the incident summary, customer was using 9-volt alkaline dura cell batteries instead of 9-volt lithium batteries (apoc list number: (b)(4)) per art: 714364-00y, of the i-stat system manual [ref.2] which has a safety feature that provides protection preventing the i-stat 1 analyzer from overheating due to component failure within the analyzer circuitry.A rocketware search spanning three months revealed no similar incidents.Over the past year, the actual number of incidents caused by reliability-related failures of tantalum capacitors was 39, which is less than the expected 185 obtained by the reliability calculations.Therefore, no corrective/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 capacitor in the c26 location.

• 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 ; pte ltd; 1 kallang place; singapore, NJ 33921-1 ; SN 339211 ; 6136123525
• MDR Report Key: 17298005
• Report Number: 2245578-2023-00086
• Device Sequence Number: 6978322
• Product Code: CGA
• UDI-Device Identifier: 00054749003709
• UDI-Public: 00054749003709
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 09/13/2023

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: 04P75-01
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2006
• 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