MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-04-09 for ST AIA-PACK 27.29 025202 manufactured by Tosoh Aia, Inc..
[16873859]
Customer account called tosoh bioscience, inc. Technical support and reported that one 27. 29 result had initially been reported as 30 u/ml with no instrument flags. Account has auto release function and the result was reported. The physician questioned the result and the specimen was pulled to be repeated at which time it was noted that there was a clot in the specimen. The clot was removed and the specimen was re-centrifuged. The specimen was repeated and the 27. 29 result was 238 u/ml. The patient's previous 27. 29 results were usually around 300 u/ml. The patient is an outpatient. Account stated that the laboratory technician had not visually checked the specimen for clots prior to the initial analysis. Root cause of the erroneous result is the presence of a clot in the specimen that was not removed prior to testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005529799-2012-00005 |
| MDR Report Key | 2536348 |
| Report Source | 06 |
| Date Received | 2012-04-09 |
| Date of Report | 2012-04-02 |
| Date Facility Aware | 2012-03-29 |
| Report Date | 2012-04-02 |
| Date Reported to FDA | 2012-04-02 |
| Date Added to Maude | 2012-04-17 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 0 |
| 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, YAMA OH 43123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 43123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ST AIA-PACK 27.29 |
| Generic Name | 27.29 |
| Product Code | CKG |
| Date Received | 2012-04-09 |
| Model Number | NA |
| Catalog Number | 025202 |
| Lot Number | TEST CUPS B819113 |
| ID Number | NA |
| Device Expiration Date | 2012-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOSOH AIA, INC. |
| Manufacturer Address | 2, IWASE KOSHI-MACHI TOYAMA 931-8510 JA 931-8510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-09 |