MAUDE Adverse Event Report: ABBOTT GMBH ASPARTATE AMINOTRANSFERASE; NADH OXIDATION/NAD REDUCTION, AST/SGOT

Catalog Number	07D81-22
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem 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 (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.(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.(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.
Additional 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.
Event or Problem 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.On (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.
Additional 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.

• Brand Name: ASPARTATE AMINOTRANSFERASE
• Common Device Name: NADH OXIDATION/NAD REDUCTION, AST/SGOT
• 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: 17551435
• Report Number: 3002809144-2023-00355
• Device Sequence Number: 6967587
• Product Code: CIT
• UDI-Device Identifier: 00380740161811
• UDI-Public: 00380740161811
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/08/2023
• Device Catalogue Number: 07D81-22
• Device Lot Number: 46771UN22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C16K PRC MOD, 03L77-01, C1601818; ARC C16K PRC MOD, 03L77-01, C1601818
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female