MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT G3+ CARTRIDGE

Catalog Number 03P78-25

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013, abbott point of care was contacted by a customer regarding i-stat g3+ cartridges, lot # n13183 that yielded unacceptable po2 results while performing calibration verification.There is no patient information or injuries associated with event.Level 4: po2 129 (range 134.4-174.4), po2 132 (range 134.4-174.4), po2 109 (range 121.6-157.8), po2 118 (range 121.6-157.8), po2 119 (range 121.6-157.8).Level 5: po2 257 (range 315.6-419.2), po2 262 (range 315.6-419.2), po2 285 (range 315.6-419.2), po2 290 (range 315.6-419.2), po2 344 (range 351.2-454.8), pco2 28.7 (range 12.51-22.31), ph 7.76 (range 7.940-8.038).

Manufacturer Narrative

(b)(4).The investigation was completed on (b)(4) 2014 and the customer complaint was confirmed through retain testing for low ph and high pco2.The lot is associated with apoc product action number: apoc2014-001, dated (b)(4) 2014.Details were provided with the action that was conducted in cooperation with the u.S.Food and drug administration.

• Brand Name: I-STAT G3+ CARTRIDGE
• Type of Device: G3+ CARTRIDGE
• Manufacturer (Section D): ABBOTT POINT OF CARE; 400 college road; princeton NJ 08540 660
• Manufacturer (Section G): ABBOTT POINT OF CARE CANADA LTD.; 185 corkstown road; ottawa, ontario K2H 8V4; CA K2H 8V4
• Manufacturer Contact: linda maczuszenko ; 400 college road; princeton, NJ 08540 ; 6136885949
• MDR Report Key: 3647031
• MDR Text Key: 4356010
• Report Number: 2245578-2014-00008
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/02/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: 03P78-25
• Device Lot Number: N13183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: APOC2014-001
• Patient Sequence Number: 1