MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-07-01 for MTS READER M MTS9940 ORTHO PROVUE manufactured by Micro Typing Systems, Inc..
[15218372]
A sample was typed incorrectly while performing a/b/o testing on the mts reader m.
Patient Sequence No: 1, Text Type: D, B5
[15584617]
The customer was performing a/b/o test preparation on the tecan megaflex id robotic pipettor and evaluating the results with the mts reader m. The customer reported a mistyped sample. A discrepancy was found between the pipetting instrument and the reader m. Mts was unable to recreate the customer issue. Customer error could not be ruled out as a contributing factor. Instrument malfunction could not be ruled out as a contributing factor. However, each reading and final test result must be reviewed and accepted by a technologist before it can be stored, printed or transmitted by the reader m. Because the correct matching of abo group between donor blood and a pt is critical to transfusion safty, the risk attendant to an individual erroneous result is significantly lessened by lab practices and regulations that require that abo grouping be established by more than one test result and by reference to historical results. Abo serum or plasma tests should always be performed as an adjunct to abo cell grouping tests. If the alleged malfunction were to recur, add'l testing will be conducted to verify abo type, preventing the misclassification of pt/donor abo type. No erroneous result were reported by the customer. The likelihood of a serious injury, while not frequent, is not remote. Mts is reporting this event based on the potential for injury should the event recur without detection by the user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2005-00062 |
| MDR Report Key | 742246 |
| Report Source | 06 |
| Date Received | 2005-07-01 |
| Date of Report | 2005-06-30 |
| Date of Event | 2005-06-03 |
| Date Mfgr Received | 2005-06-03 |
| Device Manufacturer Date | 2001-03-01 |
| Date Added to Maude | 2006-08-01 |
| 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 | 0 |
| Manufacturer Contact | CATHERINE MCMULLEN, SITE DIRECTOR |
| Manufacturer Street | 1295 SW 29TH AVENUE |
| Manufacturer City | POMPANO BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal | 33069 |
| Manufacturer Phone | 9546239537 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTS READER M |
| Generic Name | RESULT READER FOR MTS GEL CARDS |
| Product Code | KSO |
| Date Received | 2005-07-01 |
| Model Number | MTS9940 |
| Catalog Number | ORTHO PROVUE |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 730081 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US |
| Baseline Brand Name | MTS READER M |
| Baseline Generic Name | RESULT READER FOR MTS GEL CARDS |
| Baseline Model No | MTS9940 |
| Baseline Catalog No | ORTHO PROVUE |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-07-01 |