MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT RECHARGEABLE POWER PACK

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	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 01-nov-2023, abbott point of care (apoc) was contacted by a customer who reported that the rechargeable battery sometimes gets hot, and code 86 frequently occurs while using i-stat 1 analyzer sn (b)(6).The analyzer were replaced at no charge and returning for investigation.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.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.
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 25-jan-2024.Failure analysis could not be performed as analyzer s/n (b)(6), drc s/n (b)(6), and the rechargeable power pack have not been returned to flex.S/n (b)(6) and s/n (b)(6): a rocketware search spanning three months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.Rechargeable power pack: a rocketware search spanning twelve months revealed no similar incidents and no evidence of a trend.No deficiency has been identified.
Event or Problem Description
Na.

• Brand Name: I-STAT RECHARGEABLE POWER PACK
• Common Device Name: RECHARGEABLE POWER PACK
• 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; 33921 1; SN 339211
• Manufacturer Contact: linda maczuszenko ; 185 corkstown road; princeton, nj K2H 8-V4 ; CA K2H 8V4
• MDR Report Key: 18181157
• Report Number: 2245578-2023-00165
• Device Sequence Number: 7687383
• Product Code: FCO
• UDI-Device Identifier: 00054749000340
• UDI-Public: 00054749000340
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/30/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2025
• 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