MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC ALINITY C CALCIUM

Catalog Number 07P57-20

Device Problem High Test Results (2457)

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

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed falsely elevated results while using alinity c calcium reagents.The following data was provided.The customer uses normal range 2.20 to 2.55 mmol/l and results greater than 4.00 mmol/l are checked.Initial 3.84 mmol/l, repeat 2.55, 2.60 mmol/l the patient was hospitalized when the value in the normal range was obtained.No adverse impact to patient management was reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, and a review of labeling.Return material was not available from the customer.Based on the available data, it appears that a sample aspiration issue was present.A review of tracking and trending did not identify an adverse trend for issue observed by the customer.No other similar complaints were identified with this reagent lot number.Labeling was reviewed and found to be adequate.Based on this investigation this appears to be a sample specific issue.Based on the available information no deficiency of the alinity c calcium reagent (ln 7p57-20) , lot 32858un18 , was identified.

Manufacturer Narrative

Suspect medical device: catalog number was changed to ln 07p57-20 from ln 07p57-30 and the udi number (gtin) was changed to (b)(4) from (b)(4).The lot number was not changed.An evaluation is in process.

• Brand Name: ALINITY C CALCIUM
• Type of Device: CALCIUM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• MDR Report Key: 8172021
• MDR Text Key: 131001779
• Report Number: 1628664-2018-02150
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00380740135409
• UDI-Public: 00380740135409
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2019

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: 02/12/2019
• Device Catalogue Number: 07P57-20
• Device Lot Number: 32858UN18
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 12/26/2018; 02/15/2019
• Supplement Dates FDA Received: 01/04/2019; 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY C ANALYZER; ALINITY C ANALYZER; ALINITY C ANALYZER; LN 03R67-01 SN (B)(4); LN 03R67-01 SN (B)(4); LN 03R67-01 SN (B)(4)