MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY LACTATE DEHYDROGENASE2; NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE

Catalog Number 04T99-30

Device Problem High Test Results (2457)

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

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated lactate dehydrogenase2 (ldh2) results for several samples.Results provided: on (b)(6)2022 sid: (b)(6) initial result = 259 u/l, repeat result 175 u/l.On (b)(6)2022 sid: (b)(6) initial result = 341 u/l, repeat results = 179 u/l, 182 u/l, 179 u/l.On (b)(6)2022 sid: (b)(6) initial result 263 u/l, repeat results = 172 u/l, 178 u/l.On (b)(6)2022 sid: (b)(6) results: initial result = 223 u/l, repeat results = 214 u/l, 228 u/l, 219.U/l, 225 u/l, 232 u/l, 229 u/l, 247 u/l, 230 u/l, 254 u/l, 216 u/l, 240 u/l, 252 u/l, 259 u/l.(customer provided normal range 125 - 220 u/l) no impact to patient management was reported.

Event Description

Additional information provided on 25aug2022.The customer provided the additional results: (b)(6) 2022 sid (b)(6) male patient initial result = 624 u/l, repeat results = 173 u/l, 164 u/l (b)(6) 2022 sids (b)(6) female patient initial result = 313 u/l, repeat results = 228 u/l, 260 u/l, 222 u/l, 225 u/l, 226 u/l, 220 u/l, 222 u/l, 221 u/l, 222 u/l, 221 u/l, 220 u/l, 215 u/l.

Manufacturer Narrative

Additional information in section a1 - sid (b)(6), section b5, d4 expiration date, h4 manufacture date.All available patient information was included.Additional patient details are not available.This follow up is being submitted to include the initial coding in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

Event Description

The customer observed falsely elevated lactate dehydrogenase2 (ldh2) results for several samples.Results provided: 04aug2022 sid: (b)(6).Initial result = 259 u/l, repeat result 175 u/l.05aug2022 sid: (b)(6).Initial result = 341 u/l, repeat results = 179 u/l, 182 u/l, 179 u/l.04aug2022 sid: (b)(6).Initial result 263 u/l, repeat results = 172 u/l, 178 u/l.05aug2022 sid: (b)(6).Results: initial result = 223 u/l, repeat results = 214 u/l, 228 u/l, 219 u/l, 225 u/l, 232 u/l, 229 u/l, 247 u/l, 230 u/l, 254 u/l, 216 u/l, 240 u/l, 252 u/l, 259 u/l.(customer provided normal range 125 - 220 u/l).Additional information provided on 25aug2022.The customer provided the following results: 24aug2022 sid: (b)(6).Male patient initial result = 624 u/l, repeat results = 173 u/l, 164 u/l 25aug2022 sid: (b)(6).Ldh female patient initial result = 313 u/l, repeat results = 228 u/l, 260 u/l, 222 u/l, 225 u/l, 226 u/l, 220 u/l, 222 u/l, 221 u/l, 222 u/l, 221 u/l, 220 u/l, 215 u/l no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for falsely elevated alinity lactate dehydrogenase, 2 results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the issue for the product.Labeling was reviewed and found to be adequate and sufficiently addresses the customer¿s issue.Device history record review for lot 39506ud00 did not identify any non-conformances or deviations.Based on the investigation, no systemic issue or deficiency with the alinity lactate dehydrogenase 2 assay for lot 39506ud00 was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: ALINITY LACTATE DEHYDROGENASE2
• Type of Device: NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15240222
• MDR Text Key: 304103858
• Report Number: 3005094123-2022-00174
• Device Sequence Number: 1
• Product Code: CFJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• 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: 11/14/2022

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: 03/25/2023
• Device Catalogue Number: 04T99-30
• Device Lot Number: 39506UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 08/25/2022; 11/10/2022
• Supplement Dates FDA Received: 09/21/2022; 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6)