MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC CLINICAL CHEMISTRY CARBON DIOXIDE

Catalog Number 03L80-21

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up report will be submitted when the evaluation is complete.An evaluation is in process.

Event Description

The customer observed multiple falsely low carbon dioxide (co2) patient results and controls generated using the clinical chemistry carbon dioxide reagents.The following data was provided (mmol/l).Sid (b)(6) initial using lot 48549uq11 12.8, repeat using lot 48693uq01 21.1.Sid (b)(6) initial using lot 48549uq11 13.8, repeat using lot 48693uq01 22.2.Sid (b)(6) initial using lot 48549uq11 11.7, repeat using lot 48693uq01 21.3.Sid (b)(6) initial using lot 48549uq11 12.4, repeat using lot 48693uq01 20.5.Sid (b)(6) initial using lot 48549uq11 13.5, repeat using lot 48693uq01 23.9.Sid (b)(6) initial using lot 48549uq11 14.6, repeat using lot 48549uq11 8.2, 8.9, 7.8, 7.9, repeat using lot 48693uq01 20.2.No impact to patient management was reported.

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a search for similar complaints, review of batch records, and a review of labeling.No adverse trend was identified for the customer issue.Labeling was reviewed and found to be adequate.During troubleshooting, it was identified that the calibrator values were entered incorrectly.The issue was resolved after the calibrator values were corrected.Based on all available information and abbott diagnostics complaint investigation, the assay performed as intended and no product deficiency was identified.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, the device did not perform as intended.However, no systematic issue or product deficiency was identified.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 5821086
• MDR Text Key: 51112404
• Report Number: 1628664-2016-00197
• Device Sequence Number: 1
• Product Code: KHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2017

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 Date: 12/31/2016
• Device Catalogue Number: 03L80-21
• Device Lot Number: 48549UQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 07/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/11/2016; 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1