MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-08-17 for CAPTUS 3000 5430-0077 manufactured by Capintec, Inc..
[2929465]
A nuclear medicine technologist was performing a thyroid uptake procedure on a pt with i-123 using the capintec captus 3000 "measure liquid and subtract residual dose" protocol. The technologist attempted to print the pt data before completing the dose measurement sequence and got a run time error 13 message, which caused the software to exit the captus 3000 program. After logging back on to the captus 3000 program, the previously measured dose data were missing. The pt demographics data were not affected and printed correctly. Technologist confirmed that she did initially perform dose measurements. With assistance from capintec customer support, the technologist was able to complete the test manually using the multi channel analyzer (mca) program available on the captus 3000 using previously measured count data from an equivalent liquid i-123 dose. The pt did not require repeat testing.
Patient Sequence No: 1, Text Type: D, B5
[10103317]
Root cause analysis (conducted between (b)(4) 2012): the customer's error was duplicated using an identical production unit with same software revision. The root cause was identified as software programming errors which caused the following problems: if the user either exits the thyroid uptake measurement module or prints before measuring residual dose, the interim count data for the dose is not correctly saved to the pt's database. If, after exiting or printing, the user returns to the same step of the protocol without taking a measurement from another pt, an error message will be displayed and the test cannot be completed. If the user measures a different pt with the captus 3000 device before measuring the residual dose on the first pt, and then returns to the "measure liquid and subtract residual" for the first pt, the measured count data from the last measured pt will be erroneously stored in the first pt's file. This may result in an erroneous thyroid uptake value for the first pt. This software error is isolated to the "measure liquid and subtract residual" protocol only, and occurs only if the initial dose measurement sequence is interrupted. The error does not occur in any of the four other dose administration selection options in the thyroid uptake protocol setup. Corrective actions: customer alert letters were sent beginning on (b)(4) 2012 to all (b)(4) affected customers notifying them of the software error and instructing them on use of the system pending the distribution of corrected software, which is expected to be sent out within the next two weeks. Capintec will follow up with all affected customers to assure receipt and installation of corrected software. We received no reports of any illness or injury that has occurred with the use of the device related to this error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518443-2012-00001 |
| MDR Report Key | 2725019 |
| Report Source | 05 |
| Date Received | 2012-08-17 |
| Date of Report | 2012-08-15 |
| Date of Event | 2012-07-05 |
| Date Mfgr Received | 2012-07-05 |
| Device Manufacturer Date | 2012-03-01 |
| Date Added to Maude | 2012-12-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY DELL |
| Manufacturer Phone | 4129631988 |
| Manufacturer G1 | CAPINTEC, INC. |
| Manufacturer Street | 620 ALPHA DR. |
| Manufacturer City | PITTSBURGH PA 15238 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15238 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 5218443-7/18/12/0001-C, |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTUS 3000 |
| Generic Name | THYROID UPTAKE AND WELL COUNTER SYSTEM |
| Product Code | JJJ |
| Date Received | 2012-08-17 |
| Model Number | CAPTUS 3000 |
| Catalog Number | 5430-0077 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAPINTEC, INC. |
| Manufacturer Address | 6 ARROW ROAD RAMSEY NJ 07446 US 07446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-17 |