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U.S. Department of Health and Human Services

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

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ABBOTT POINT OF CARE I-STAT CHEM8+ CARTRIDGE Back to Search Results
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.
 
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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 Key4729792
MDR Text Key20154393
Report Number2245578-2015-00018
Device Sequence Number1
Product Code CHL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K053110
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/14/2015
Device Catalogue Number09P31-25
Device Lot NumberH14321
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/28/2015
Initial Date FDA Received04/27/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/12/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age48 YR
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