MAUDE Adverse Event Report: ABBOTT IRELAND ALINITY I STAT CK-MB REAGENT KIT; FLUOROMETRIC METHOD, CPK OR ISOENZYMES

Catalog Number 04V38-20

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2021

Event Type  malfunction  

Event Description

The account generated false elevated alinity i stat ck-mb with a patient who received an unnecessary coronary arteriography.The patient (age (b)(6), gender male, race/ethnicity (b)(6)) with pituitary tumors (b)(6) 2021 admitted.(b)(6).No adverse outcome or additional patient harm due to the cag.

Manufacturer Narrative

(b)(6).This report is being filed on an international product list 4v38-20/30, that has a similar us product distributed in the us, list 4v38-21/31.The evaluation is in process.A followup report will be submitted when the evaluation is complete.

Manufacturer Narrative

Section b.5 additional information provided.The evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

Additional information provided.The patient was hospitalized on (b)(6) 2021 for a pituitary tumor removal operation.The account questioned the elevated results and performed sample interference testing.As part of troubleshooting, dilution linearity and hbt testing was performed with similar results as original testing.On 22sep2021 data: ck-mb run 1: 43.7 ng/ml(original), 25.2 (1:2 dilution), 12.9 (1:4 dilution), 6.5 (1:8 dilution).Run 2: 43.3 ng/ml(original), 25.7 (1:2 dilution), 12.8 (1:4 dilution), 6.9 (1:8 dilution).Hbt: ck-mb 44.1 pg/ml.Hstni run 1: 24479.7 pg/ml(original), 11512.9 (1:2 dilution), 5643.5 (1:4 dilution), 2584.1 (1:8 dilution).Run 2: 22799.8 pg/ml(original), 11205.2 (1:2 dilution), 5319.0 (1:4 dilution), 2677.3 (1:8 dilution).Hbt: hstni 24815.8 pg/ml.Nt-probnp run 1: 15658.1 pg/ml(original), 7378.4 (1:2 dilution), 3563.2 (1:4 dilution), 1664.9 (1:8 dilution).Run 2: 15068.9 pg/ml(original), 7492.0 (1:2 dilution), 3458.1 (1:4 dilution), 1698.4 (1:8 dilution).Hbt: nt-probnp 15688.6 pg/ml.

Manufacturer Narrative

Section g.1 updated contact name, email, address, phone, fax data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A ticket search for likely cause lot 26003fn00 did not identify an increase in complaint activity related to the issue under review.A review of ticket trending data for the alinity i stat ck-mb assay was performed with no adverse trends identified.A device history review was performed on the likely cause lot 26003fn00 which did not show any non-conformances, deviations, or potential non-conformances.Labeling was reviewed and found to adequately address the issue under review.As part of the investigation, a cross functional team (cft) was formed to review the adverse event.The cft determined this not to be an adverse event due to the alinity i stat ck-mb results being correct for this patient given the history and additional information provided that the values show the significant rise in values during the patient¿s hospital stay.Suggesting that they were already under cardiac stress prior to surgery and post-surgery.Based on the information provided in the complaint text, the cft have determined the elevated results obtained post-surgery and the path taken to perform a coronary arteriography was correct and thus deeming this not to be an adverse event.A malfunction was not identified.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.No product deficiency was identified.Section g.1 updated contact name, email, address, phone, fax.

• Brand Name: ALINITY I STAT CK-MB REAGENT KIT
• Type of Device: FLUOROMETRIC METHOD, CPK OR ISOENZYMES
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; EI N39 E932 ; 2246682940
• MDR Report Key: 12585353
• MDR Text Key: 281671297
• Report Number: 3008344661-2021-00180
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2022
• Device Catalogue Number: 04V38-20
• Device Lot Number: 26003FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI05270; ALNTY I PROCESSING MODU, 03R65-01, AI05270; ALNTY I PROCESSING MODU, 03R65-01, AI05270
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian