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 2017-09-08 for AIA-2000 022101 manufactured by Tosoh Hi-tec.
[86132383]
(b)(4). Device evaluation by manufacturer: on 14-aug-2017 a field service engineer (fse) inspected the aia-2000 analyzer for leaks or abnormalities and none were found. The fse also ran daily check. The fse could not duplicate the reported the reported event. The aia-2000 was performing within specifications. A 13-month complaint history review for serial number (b)(4) found no other similar complaints during this time period. The root cause of the reported discrepant t4 patient result could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[86132384]
On (b)(6) 2017 a customer reported a t4 (thyroxine) patient result of 1. 93 ug/dl and upon repeat it was 1. 42 ug/dl (normal range 0. 5 - 24 ug/dl). The customer reported that bio-rad quality controls (qc) were within acceptable range. The customer reported that the sample was clotted for 30 to 60 minutes and spun for 10 minutes. The customer runs samples and qc in insert cups inside the original barcoded tubes. Some samples are frozen, but the customer did not know if the sample in question was. The customer stated that the sample in question was not reported out of the laboratory. There is no indication of any patient intervention or adverse health consequences due to this event.
Patient Sequence No: 1, Text Type: D, B5
[116781669]
(b)(4). Report source: under the above section "user facility" was incorrectly selected. The only report source is "health professional".
Patient Sequence No: 1, Text Type: N, H10
[116781670]
N/a.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031673-2017-00026 |
| MDR Report Key | 6853993 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-08 |
| Date of Report | 2018-10-25 |
| Date of Event | 2017-08-10 |
| Date Facility Aware | 2018-09-12 |
| Report Date | 2018-10-25 |
| Date Reported to FDA | 2018-10-25 |
| Date Reported to Mfgr | 2018-10-25 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2017-09-08 |
| 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-2000 |
| Generic Name | AIA-2000 |
| Product Code | CDX |
| Date Received | 2017-09-08 |
| Model Number | AIA-2000 |
| Catalog Number | 022101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 13 MO |
| Device Eval'ed by Mfgr | Y |
| 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-2000 |
| Generic Name | AIA-2000 |
| Product Code | KHO |
| Date Received | 2017-09-08 |
| Model Number | AIA-2000 |
| Catalog Number | 022100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-09-08 |