AIA-900 022930111

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-08-14 for AIA-900 022930111 manufactured by Tosoh Hi-tec.

Event Text Entries

[83099629] Mdr is being submitted late because of difficulties setting up the user account through the electronic submissions gateway (esg) system. Contact office - name/address (and manufacturing site for devices): (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[83099630] On (b)(6)2017 customer reported quality control (qc) was lower than expected and lower folate results were also seen with 7 patient samples. Customer repeated calibration, which increased the patients' results. Normal range for folate is 3 - 16 ng/ml: pre-calibration patient 1 = 2. 42 ng/ml / post-calibration 3. 13 ng/ml. Pre-calibration patient 2 = 3. 56 ng/ml / post-calibration 4. 44 ng/ml. Pre-calibration patient 3 = 5. 19 ng/ml / post-calibration 6. 32 ng/ml. Pre-calibration patient 4 = 18. 69 ng/ml / post-calibration >20. 0 ng/ml*. Pre-calibration patient 5 = 6. 24 ng/ml / post-calibration 7. 3 ng/ml pre-calibration patient 6 = 14. 63 ng/ml / post-calibration 17. 1 ng/ml*. Pre-calibration patient 7 = 3. 14 ng/ml / post-calibration 3. 96 ng/ml. * these patient results were inside the acceptable range prior to recalibration. The customer reported that although results changed, there was no modification to any of the patients' treatment plan. A contributing factor to the reported issue by the customer was most likely a minor lot to lot variability. The aia-900 is performing as designed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8031673-2017-00009
MDR Report Key6793417
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-08-14
Date of Report2017-12-28
Date of Event2017-06-27
Date Facility Aware2017-06-27
Report Date2017-12-28
Date Reported to FDA2017-12-28
Date Reported to Mfgr2017-12-28
Date Mfgr Received2017-06-27
Device Manufacturer Date2008-05-01
Date Added to Maude2017-08-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. DORIA ESQUIVEL
Manufacturer Street6000 SHORELINE COURT SUITE 101
Manufacturer CitySOUTH SAN FRANCISCO CA 94080
Manufacturer CountryUS
Manufacturer Postal94080
Manufacturer Phone6506368123
Manufacturer G1TOSOH BIOSCIENCE, INC. (IMPORTER)
Manufacturer Street6000 SHORELINE COURT SUITE 101
Manufacturer CitySOUTH SAN FRANCISCO CA 94080
Manufacturer CountryUS
Manufacturer Postal Code94080
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameAIA-900
Generic NameAIA-900
Product CodeCGN
Date Received2017-08-14
Model NumberAIA-900
Catalog Number022930111
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age9 YR
Device Eval'ed by MfgrN
Device Sequence No0
Device Event Key0
ManufacturerTOSOH HI-TEC
Manufacturer Address1-37 FUKUGAWA MINAMI-MACHI SHUNAN-SHI 746-0042, JA, JA

Device Sequence Number: 1

Brand NameAIA-900
Generic NameAIA-900
Product CodeKHO
Date Received2017-08-14
Model NumberAIA-900
Catalog Number022930111
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age9 YR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTOSOH HI-TEC
Manufacturer Address1-37 FUKUGAWA MINAMI-MACHI SHUNAN-SHI 746-0042, JA, JA


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-14

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