MAUDE Adverse Event Report: ABBOTT GMBH ALANINE AMINOTRANSFERASE; NADH OXIDATION/NAD REDUCTION, ALT/SGPT

Catalog Number 07D56-22

Device Problem High Test Results (2457)

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

Event Date 07/24/2023

Event Type  malfunction  

Event Description

The customer stated that falsely elevated architect aspartate aminotransferase (ast) and alanine aminotransferase (alt) results were generated for a pregnant patient.The following data was provided.(b)(6), 2023 sid (b)(6), architect aspartate aminotransferase (ast) result: 302 u/l, architect alanine aminotransferase (alt) result: 205 u/l.Later the same day, the same sample was retested.Architect aspartate aminotransferase (ast) results: 25, 26 and 26 u/l, architect alanine aminotransferase (alt) results: 21, 21 and 21 u/l.A second sample was collected the same day.Sid (b)(6), architect aspartate aminotransferase (ast) results: 27 and 26 u/l, architect alanine aminotransferase (alt) results: 20 and 20 u/l.A third sample was also collected.Sid (b)(6), architect aspartate aminotransferase (ast) result: 25 u/l, architect alanine aminotransferase (alt) result: 21 u/l.The initial elevated results were reported out of the lab.Additional laboratory results were not available, but the customer stated there were no other abnormal results.The patient's presenting symptoms were not available from the customer.Based on the elevated ast and alt results, the patient was induced to give birth due to the risk of gestosis.The type/dose of medication used for induction was not available.The patient was 38 weeks and 4 days pregnant.The patient did not deliver the baby at that time as the doctor stopped the induction after she received the repeat values which were normal.The patient delivered the baby 2 weeks later.The customer stated there was no harm to the patient or the baby.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.

Manufacturer Narrative

After further evaluation, the suspect medical device was updated on august 29, 2023.Mdr number 3016438761-2023-00477 has been submitted for the new suspect medical device and all further information will be documented under that mdr number.H3 other text : see section h10.

Event Description

The customer stated that falsely elevated architect aspartate aminotransferase (ast) and alanine aminotransferase (alt) results were generated for a pregnant patient.The following data was provided.July 24, 2023, sid (b)(6).Architect aspartate aminotransferase (ast) result: 302 u/l.Architect alanine aminotransferase (alt) result: 205 u/l.Later the same day, the same sample was retested.Architect aspartate aminotransferase (ast) results: 25, 26 and 26 u/l.Architect alanine aminotransferase (alt) results: 21, 21 and 21 u/l.A second sample was collected the same day.Sid (b)(6).Architect aspartate aminotransferase (ast) results: 27 and 26 u/l.Architect alanine aminotransferase (alt) results: 20 and 20 u/l.A third sample was also collected.Sid (b)(6).Architect aspartate aminotransferase (ast) result: 25 u/l.Architect alanine aminotransferase (alt) result: 21 u/l.The initial elevated results were reported out of the lab.Additional laboratory results were not available, but the customer stated there were no other abnormal results.The patient's presenting symptoms were not available from the customer.Based on the elevated ast and alt results, the patient was induced to give birth due to the risk of gestosis.The type/dose of medication used for induction was not available.The patient was 38 weeks and 4 days pregnant.The patient did not deliver the baby at that time as the doctor stopped the induction after she received the repeat values which were normal.The patient delivered the baby 2 weeks later.The customer stated there was no harm to the patient or the baby.

• Brand Name: ALANINE AMINOTRANSFERASE
• Type of Device: NADH OXIDATION/NAD REDUCTION, ALT/SGPT
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17552684
• MDR Text Key: 321734407
• Report Number: 3002809144-2023-00356
• Device Sequence Number: 1
• Product Code: CKA
• UDI-Device Identifier: 00380740161651
• UDI-Public: 00380740161651
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07D56-22
• Device Lot Number: 63076Q10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC C16K PRC MOD, 03L77-01, C1601818; ARC C16K PRC MOD, 03L77-01, C1601818
• Patient Outcome(s): Other
• Patient Sex: Female