MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-24 for AIA-360 019945 manufactured by Tosoh Hi-tec, Inc.,.
[22092489]
Imprecision, account called, had run two different pts and results 3. 0 for troponin. Account repeated with new samples one hr later and both pts were less than low. Account repeated first two samples and results less than low. Other instrument performing as expected. No error codes on printout. Field service engineer notified. On (b)(6) 2011, pts transferred to ccu due to high ctn on initial sample that was run. Called to find out if pts were actually treated. Tech to discuss with physician. On (b)(4) 2011 f/u: pt treatment. No response. On (b)(4) 2011 f/u: info given to pathologist who had not yet responded. Unclear to him as to whether treatment was affected. One received heparin drip related to high ctn. Other than that no interventions were done. He was told a bead was stuck on the wash probe tip. Notified technical support mgr.
Patient Sequence No: 1, Text Type: D, B5
[22134474]
Service report info. On (b)(6) 2011 - customer had run a calibration with test cup lot# a919372 and controls which recovered within range in the am before field service engineer arrived and running pts on analyzer. Calibrator lot# az39338, controls bio-rad liquichek lot# 23500, substrate lot# 1y60030 exp date 03/26/2011, wash lot# 1x70011 exp date 04/21/2011, diluent lot# 1780034 exp date 04/15/2011, test cup lot# a919370 exp date: 09/2011. Found bead lodged in tip of b/f wash probe. Cleaned. Checked substrate temp, high at 41. 5 degrees adjusted to 39. 5 degrees. Checked wash heater temp at 40. 5 degrees adjusted to 39. 7 degrees. Table temp at 37. 3 degrees. Found spot on detector lens, cleaned. Checked error codes, only listing for (b)(6) was 2014 and 3018 errors. The 3018 error is for a full waste container, 2014 for not enough sample. Performed sample level detection calibration for the 2014 error code. Tube values within specimen cup values, low 140's should be 180-200 adjusted from 140 to 183. Verified operation of all syringes, pumps and b/f wash probe. Ran tosoh calibrators lot az39388. Ran bio-rad liquichek lots 23501 and 23503 control #1 and #3. The #1 range 0. 27-0. 93, recovered at 0. 46, #3 range 28. 2-46. 9 recovered at 37. 78. Ran n=10 precision run on #1 and #3 control. The #1 mean = 0. 379, sd= 0. 011, %cv= 2. 95, #3 mean= 32. 07, sd= 0. 67, %cv= 2. 09. No further action required by tbi field service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005529799-2011-00005 |
| MDR Report Key | 2064110 |
| Report Source | 06 |
| Date Received | 2011-03-24 |
| Date of Report | 2011-03-24 |
| Date of Event | 2011-03-21 |
| Date Facility Aware | 2011-03-23 |
| Report Date | 2011-03-24 |
| Date Reported to FDA | 2011-03-24 |
| Device Manufacturer Date | 2000-07-01 |
| Date Added to Maude | 2011-12-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SUSAN KOSS |
| Manufacturer Street | 3600 GANTZ ROAD |
| Manufacturer City | GROVE CITY OH 43123 |
| Manufacturer Country | US |
| Manufacturer Postal | 43123 |
| Manufacturer Phone | 6143171909 |
| Manufacturer G1 | TOSOH HI-TEC, INC., |
| Manufacturer Street | 1-37 FUKUGAWA MINAMO MACHI SHUNAN-SHI |
| Manufacturer City | YAMAGUCHI, YAMAGUTI 746-0042 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 746-0042 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIA-360 |
| Generic Name | AUTOMATED IMMUNOASSAY ANALYZER |
| Product Code | OMI |
| Date Received | 2011-03-24 |
| Model Number | AIA-360 |
| Catalog Number | 019945 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOSOH HI-TEC, INC., |
| Manufacturer Address | 1-37 FUKUGAWA MINAMO MACHI SHUNAN-SHI YAMAGUCHI, YAMAGUTI 746-0042 JA 746-0042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-24 |