MAUDE Adverse Event Report: ABBOTT LABORATORIES CLINICAL CHEMISTRY CARBON DIOXIDE

Catalog Number 03L80-31

Device Problem High Test Results (2457)

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

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely depressed co2 results on the architect c16000 analyzer.The following data was provided: initial 13.4, repeat 18.4, 22 meq/l.There was no impact to patient management reported.Neat sample - 13.4: when the sample was diluted, one part sample to one part saline, the final (calculated) result was 18.4.When the sample was diluted, one part sample to two parts saline, the final (calculated) result was 22.The patients acidosis is normal on blood gas analysis with a normal blood ph and bicarbonate result.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs and a review of labeling.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation, the assay and analyzer performed as intended and no product deficiency was identified.

Manufacturer Narrative

The conclusion code was corrected to (b)(4).The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended, however, no systemic issue or product deficiency was identified.Additionally, the incorrect manufacturing site was identified on 5/18/2017.Manufacturing report 1628664-2017-00235 has been submitted and all further information will be documented in that report.

• Brand Name: CLINICAL CHEMISTRY CARBON DIOXIDE
• Type of Device: CARBON DIOXIDE
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• Manufacturer (Section G): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• 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: 5911247
• MDR Text Key: 53399347
• Report Number: 1415939-2016-00092
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740005962
• UDI-Public: 00380740005962
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/26/2017

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: 04/30/2017
• Device Catalogue Number: 03L80-31
• Device Lot Number: 49188UQ03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2016
• Initial Date FDA Received: 08/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/13/2016; 05/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2016
• 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
• Treatment: LN 03L77-01, SN: (B)(4)