MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CARBON DIOXIDE REAGENT KIT; ENZYMATIC, CARBON-DIOXIDE

Model Number 07P7220

Device Problem High Test Results (2457)

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

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: multiple = sid: (b)(6).All available patient information has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely elevated alinity c co2 results on multiple patients.The results provided were (customers normal range 23 to 31 mmol/l): on (b)(6) 2020, a (b)(6)-year-old female; sid: (b)(6); initial = 34.7 mmol/l, repeated = 21.5 mmol/l.On (b)(6) 2020, a (b)(6)-year-old male, sid: (b)(6); initial = 34.3 mmol/l, repeated = 22.4 mmol/l; on (b)(6) 2020, a (b)(6)-year-old female; sid: (b)(6); initial = 36.7 mmol/l, repeated = 25.8 mmol/l; on (b)(6) 2020, a (b)(6)-year-old female; sid: (b)(6); initial = 35.0 mmol/l, repeated = 25.8 mmol/l; on (b)(6) 2020, a (b)(6)-year-old male; sid: (b)(6); initial = 39.6 mmol/l, repeated = 25.4 mmol/l.No impact to patient management was reported.

Manufacturer Narrative

A review of tickets determined that there is normal complaint activity for lot number 56877uq02.A review of tracking and trending did not identify any trends for elevated patient results due to the product.Return testing was not completed as returns were not available.Retesting of the samples gave expected normal results.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of alinity co2 reagent ((b)(4)) lot number 56877uq02 was identified.

• Brand Name: ALINITY C CARBON DIOXIDE REAGENT KIT
• Type of Device: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10777327
• MDR Text Key: 214813189
• Report Number: 3002809144-2020-01077
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: 00380740121594
• Combination Product (y/n): N
• PMA/PMN Number: K060295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

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: 03/31/2021
• Device Model Number: 07P7220
• Device Catalogue Number: 07P72-20
• Device Lot Number: 56877UQ02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, AC02376; ALNTY C PROCESSING MODU, 03R67-01, AC02376