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.
[83749090]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83749091]
On (b)(6) 2017 the customer reported a patient sample ran on (b)(6) 2017 had a testosterone result of 91 ng/dl (normal male range 199 - 1586 ng/dl). This sample was also sent out to a reference lab (lcms methodology) and reported out
| Report Number | 8031673-2017-00010 |
| MDR Report Key | 6793452 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-14 |
| Date of Report | 2017-12-27 |
| Date of Event | 2017-02-03 |
| Date Facility Aware | 2017-02-03 |
| Report Date | 2017-12-27 |
| Date Reported to FDA | 2017-12-27 |
| Date Reported to Mfgr | 2017-12-27 |
| Date Mfgr Received | 2017-02-03 |
| Device Manufacturer Date | 2005-04-01 |
| 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 | CDZ |
| Date Received | 2017-08-14 |
| Model Number | AIA-900 |
| Catalog Number | 022930111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 12 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 | 12 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 |