MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CARTRIDGE; I-STAT CARTRIDGES

Catalog Number B5

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Event Description

A remedial action has been completed to provide recommendations to the customer for product in the field.The i-stat cg8+ cartridge contains eight measured tests (sodium, potassium, ionized calcium, ph, pco2, po2, glucose and hematocrit) and the i-stat eg7+ cartridge contains seven measured tests (sodium, potassium, ionized calcium, ph, pco2, po2, and hematocrit).The test for ionized calcium, as part of the i-stat system, is intended for use in the in vitro quantification of ionized calcium in arterial, venous, or capillary whole blood.The i-stat cg8+ and eg7+ cartridge instructions for use (ifu) indicate that these cartridges can be stored for 2 months at room temperature (18 to 30°c).Abbott routinely tests the performance of i-stat cartridges, including stability testing of the i-stat cg8+ and eg7+ cartridges at various time intervals after storage in the refrigerator and at 30°c.Through this internal testing process after storage at 30°c for 14 days, abbott point of care observed approximately 5.2% of cartridges reporting higher than expected results for ionized calcium.Abbott point of care observed ionized calcium on some i-stat cg8+ and eg7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30°c) for periods of time in excess of: 3 days for lot numbers 20100 to 20339 7 days for lot numbers 20340 and above where = lot letter a, k, l, m, n, w or y.Abbott point of care has not observed higher than expected reported results for the ionized calcium test when i-stat cg8+ and eg7+ cartridges are removed from refrigerated storage and warmed to room temperature for use within the number of days indicated above.Abbott point of care has not observed this issue for any tests on the i-stat cg8+ or eg7+ other than the ionized calcium test.Abbott point of care is communicating this information to potentially impacted customers.Clinicians should be advised to consider a patient's signs, symptoms, history, and results of other diagnostic tests when interpreting the ionized calcium results from these cartridges.If the results do not match the patient's clinical presentation, the patient sample should be retested using an alternate i-stat cartridge or method.Treatment of falsely high ionized calcium may result in harm, by precipitating hypocalcemia.Abbott point of care has not received any reports of patient harm associated with this issue.This action has been communicated to the u.S.Food and drug administration.Product name: i-stat cg8+ cartridges, list number: 03p88-25, udi: (b)(4), 510k: k940918.Product name: i-stat eg7+ cartridges, list number: 03p76-25, udi: (b)(4), 510k: k940918.

• Brand Name: I-STAT CARTRIDGE
• Type of Device: I-STAT CARTRIDGES
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 6607
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; K2H 8 V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540-3629 ; 6136885949
• MDR Report Key: 11058548
• MDR Text Key: 242904755
• Report Number: 2245578-2020-00134
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: B5
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: APOC2020-007
• Patient Sequence Number: 1