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

Catalog Number 03P75-99

Device Problems Overheating of Device (1437); Difficult or Delayed Activation (2577); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, abbott point of care (apoc) was contacted by a customer who reported that analyzer sn (b)(4) would not activate.The customer states that the battery was felt hot to touch, as well as the replacement battery that was installed in the analyzer.The customer states the analyzer was operating with disposable batteries and a red (fused) battery carrier.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 battery carrier was being used.Therefore the analyzer is unlikely to become hot to touch.The product was replaced and returning for investigation.Based on the information available, there were no patient or user related injuries associated with this complaint.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The investigation was completed on 07/01/2015.Failure analysis confirmed the inability to activate analyzer s/n (b)(4), and signs of drop damage were noted, including missing recharge contact pins.During the visual inspection of the main board, a piece of a missing recharge contact pin was found on top of the capacitor c123.There were no burned or damaged components found on the main board, on the battery contact printed circuit board, or on the wireless module.The recharge contact pin was removed from capacitor c123 and the analyzer was re-cased.The analyzer was powered up without any quality check codes or messages.External simulator ((b)(4)) was run five times and all runs passed.Five eg7+ cartridges (lot# n15025, expiration date: 09/14/2015) were run using calibrant l (lot# l50129, expiration date: 07/28/2015).No qc codes, messages, or anomalies were observed with the removal and insertion of each successive cartridge.The conclusion is that as a result of drop damage at the customer site, the recharge contact pin that was shunted on capacitor c123 created a short circuit between vbb and ground; current flowing through the capacitor/shunt likely caused the battery to become hot to touch at the customer site.

• 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 660
• Manufacturer (Section G): FLEXTRONICS MANUFACTURING (SINGAPORE); pte ltd; 1 kallang place; singapore 3392 11; SN 339211
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 4719801
• MDR Text Key: 5580852
• Report Number: 2245578-2015-00014
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03P75-99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1