MAUDE Adverse Event Report: TOSOH AIA, INC. ST AIA-PACK INTACT PARATHYROID HORMONE

Model Number	N/A
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was performed in response to a complaint of intact parathyroid hormone (ipth) quality control (qc) is out low on the aia-360 analyzer.The device was being used for diagnosis during the complaint event.The technical support specialist (tss) shipped customer a new test cup and followed up with the site after a few days.Customer confirmed that the qc was now in range.The "outcome" revealed that there was possibly an issue with the reagent, revealed that there was possibly an issue with the reagent.Review of the investigation conclusions indicates that escalation of the complaint for corrective and preventive actions is not warranted.A 13-month complaint and service history review for serial number (b)(4) from the date of 08sep2020 through aware date (b)(6) 2021 was performed for similar complaints.There were no similar complaints identified during the search period.A 13-month complaint and service history review for lot number b545282 from the date of 08sep2020 through aware date (b)(6) 2021 was performed for similar complaints.There were no similar complaints identified during the search period.
Event or Problem Description
Customer reported that the quality control (qc) on the intact parathyroid hormone (ipth) was low.This is a reportable event based on delay in reporting of patient results for ipth.
Additional Manufacturer Narrative
An investigation was performed in response to a complaint of intact parathyroid hormone (ipth) quality control (qc) is out low on the aia-360 analyzer.The device was being used for diagnosis during the complaint event.The technical support specialist (tss) shipped customer a new test cup and followed up with the site after a few days.Customer confirmed that the qc was now in range.The "outcome" revealed that there was possibly an issue with the reagent, revealed that there was possibly an issue with the reagent.Review of the investigation conclusions indicates that escalation of the complaint for corrective and preventive actions is not warranted.A 13-month complaint and service history review for serial number (b)(4) from the date of 08sep2020 through aware date (b)(6) 2021 was performed for similar complaints.There were no similar complaints identified during the search period.A 13-month complaint and service history review for lot number b545282 from the date of 08sep2020 through aware date (b)(6) 2021 was performed for similar complaints.There were no similar complaints identified during the search period.
Event or Problem Description
Customer reported that the quality control (qc) on the intact parathyroid hormone (ipth) was low.This is a reportable event based on delay in reporting of patient results for ipth.

• Brand Name: ST AIA-PACK INTACT PARATHYROID HORMONE
• Common Device Name: ST AIA-PACK INTACT PARATHYROID HORMONE
• Manufacturer (Section D): TOSOH AIA, INC.; 2, iwasekoshi-machi; toyama, toyoma 93185 10; JA 9318510
• Manufacturer (Section G): TOSOH AIA, INC.; 2, iwasekoshi-machi; toyama, toyoma 93185 10; JA 9318510
• Manufacturer Contact: bernadette o connell ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368143
• MDR Report Key: 12791663
• Report Number: 9612316-2021-00001
• Device Sequence Number: 14691323
• Product Code: CEW
• UDI-Device Identifier: 14560189210445
• UDI-Public: 14560189210445
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 025413
• Device Lot Number: B545282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown