AIA-2000 022101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-10 for AIA-2000 022101 manufactured by Tosoh Corporation.

Event Text Entries

[97778357] (b)(4). Device evaluation by manufacturer: on (b)(6) 2017 a field service engineer (fse) ran b12 on two (2) patient samples nine (9) times; the patient results upon repeat were within acceptable range. Quality controls were within acceptable range as well. The precision coefficient of variation (%cv) on both patient samples was within acceptable range. The fse could not duplicate the reported event. The aia-2000 was operating within specifications. A 13-month complaint history review and service history review for similar complaints was performed for aia-2000, serial number (b)(4), from 11-nov-2016 through 11-dec-2017. There were three (3) similar complaints identified during the searched period, which includes this event. The vitamin b12 aia-pack b12 assay specifications under limitations of the procedure, page 9, states the following: for diagnostic purposes, the results obtained from this assay should be used in conjunction with other data (e. G. Symptoms, results of other tests, clinical impressions, therapy, etc. ). The cause of the reported event could not be determined. The aia-2000 was operating within specifications.
Patient Sequence No: 1, Text Type: N, H10

[97778358] On (b)(6) 2017 a customer reported random b12 patient results falling below the reference range on the aia-2000, which upon repeat results were much higher. There is no indication of any patient intervention or adverse health consequences due to the discrepant patient results.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8031673-2017-00263
• MDR Report Key: 7181319
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2018-01-10
• Date of Report: 2018-01-10
• Date of Event: 2017-12-11
• Date Facility Aware: 2017-12-11
• Report Date: 2018-01-10
• Date Reported to FDA: 2018-01-10
• Date Reported to Mfgr: 2018-01-10
• Date Mfgr Received: 2017-12-11
• Device Manufacturer Date: 2017-02-01
• Date Added to Maude: 2018-01-10
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. DORIA ESQUIVEL
• Manufacturer Street: 6000 SHORELINE COURT SUITE 101
• Manufacturer City: SOUTH SAN FRANCISCO CA 94080
• Manufacturer Country: US
• Manufacturer Postal: 94080
• Manufacturer Phone: 6506368123
• Manufacturer G1: TOSOH BIOSCIENCE, INC. (IMPORTER)
• Manufacturer Street: 6000 SHORELINE COURT SUITE 101
• Manufacturer City: SOUTH SAN FRANCISCO CA 94080
• Manufacturer Country: US
• Manufacturer Postal Code: 94080
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: AIA-2000
• Generic Name: AIA-2000
• Product Code: CDD
• Date Received: 2018-01-10
• Model Number: AIA-2000
• Catalog Number: 022101
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 4 MO
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: TOSOH CORPORATION
• Manufacturer Address: SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA MINATO-KU, TOKYO, 105-8623 JA 105-8623

Device Sequence Number: 1

• Brand Name: AIA-2000
• Generic Name: AIA-2000
• Product Code: KHO
• Date Received: 2018-01-10
• Model Number: AIA-2000
• Catalog Number: 022101
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 4 MO
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TOSOH CORPORATION
• Manufacturer Address: SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA MINATO-KU, TOKYO, 105-8623 JA 105-8623

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-01-10