MAUDE Adverse Event Report: ABBOTT POINT OF CARE I-STAT CHEM8+ CARTRIDGE

Catalog Number 09P31-25

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/23/2015

Event Type  malfunction  

Event Description

On 04/02/2015, an abbott point of care sales support representative was contacted by a customer who reported that i-stat cartridges yielded a discrepant hematocrit/hemoglobin on a (b)(6) female patient.There was no other additional patient information available at the time of this report.Cartridge lot number is unknown at the time of this report.Date: (b)(6) 2015, method: unk, result time: unk, hct: unk, hb: 135, comment: pre-admin testing, patient lost 3 liters of blood; (b)(6) 2015, i-stat, 1608, 0.23, 78, patient received treatment of colloids; (b)(6) 2015, i-stat, 1709, 0.52, 177, sample sent to laboratory for hematocrit testing; (b)(6) 2015, lab, unk, unk, 68, patient was given 3 units of blood based on lab result.Per i-stat1 system manual (art: 714178-00p.Rev.Date 12-feb-14), hematocrit results are affected by the level of total protein as follows: hct increased by ~0.75 %pcv for each increase 1 g/dl tp.At this time there is reason to believe that a malfunction exists based on the information available.An investigation will be initiated when product information (cartridge lot#) becomes available.There are no injuries associated with this event.

Manufacturer Narrative

Apoc incident # (b)(4).Cartridge lot is unknown at this time.

Manufacturer Narrative

(b)(4).At the time of the initial report there was no lot information available.A search was performed where chem8+ cartridge lot numbers were shipped to abbott (b)(4) between (b)(6)-2015 and (b)(6)-2015 and the following lots were identified (below): lot number: h14355, shipping date: (b)(6)-2015; lot number: h15005, shipping date: (b)(6)-2015; lot number: h15016a, shipping date: (b)(6)-2015; lot number: h15036, shipping date: (b)(6)-2015; lot number: h15053, shipping date: (b)(6)-2015.The investigation was completed on 05/28/2015 for the lots listed above.Retain cartridges were tested and are functioning according to specification.Return product was not available for investigation.On 06/03/2015 new information was received and the customer confirmed that lots h14321 and h15005 were used during the event on (b)(6) 2015.Lot# h14321 was not included in the initial investigation.A revision of the investigation was completed on (b)(6) 2015 which included chem8+ lot# h14321.Retain cartridges were tested and are functioning according to specification.

• Brand Name: I-STAT CHEM8+ CARTRIDGE
• Type of Device: CHEM8+ 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: 4729792
• MDR Text Key: 20154393
• Report Number: 2245578-2015-00018
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K053110
• 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: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2015
• Device Catalogue Number: 09P31-25
• Device Lot Number: H14321
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR