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.
[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
| Report Number | 8031673-2017-00009 |
| MDR Report Key | 6793417 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-14 |
| Date of Report | 2017-12-28 |
| Date of Event | 2017-06-27 |
| Date Facility Aware | 2017-06-27 |
| Report Date | 2017-12-28 |
| Date Reported to FDA | 2017-12-28 |
| Date Reported to Mfgr | 2017-12-28 |
| Date Mfgr Received | 2017-06-27 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2017-08-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 |
| Brand Name | AIA-900 |
| Generic Name | AIA-900 |
| Product Code | CGN |
| Date Received | 2017-08-14 |
| Model Number | AIA-900 |
| Catalog Number | 022930111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | TOSOH HI-TEC |
| Manufacturer Address | 1-37 FUKUGAWA MINAMI-MACHI SHUNAN-SHI 746-0042, JA, JA |
| Brand Name | AIA-900 |
| Generic Name | AIA-900 |
| Product Code | KHO |
| Date Received | 2017-08-14 |
| Model Number | AIA-900 |
| Catalog Number | 022930111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 9 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOSOH HI-TEC |
| Manufacturer Address | 1-37 FUKUGAWA MINAMI-MACHI SHUNAN-SHI 746-0042, JA, JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-14 |