MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for SYSMEX SP-50 BX765805 manufactured by Sysmex Ra Co., Ltd. Main Plant.
[133537316]
A service engineer (se) was dispatched and unable to find any technical issues with the slide preparer. All other patient samples printed correctly. Sysmex corporation (b)(4) (s-corp) performed the investigation and determined a software program defect contributed to the event. The internal processing unit (ipu) transmits patient information to the device control manager (dcm) program. The dcm program then sends the patient information to the printer. The ipu program is allowed 25 seconds to transmit patient information to the dcm program. S-corp found the transmission of the patient information from the ipu program to the dcm program was delayed greater than 25 seconds. The dcm program did not wait for the patient information to be transmitted and erroneously instructed the printer to print the previous patient information on the slide. S-corp is developing a countermeasure to resolve the issue. The countermeasure will include reducing the delay of transmission of patient information from the ipu program to the dcm program and requiring the dcm to delete all patient information after printing. When blood smears are misidentified, there is a risk for incorrect differential result reporting. Physicians who are familiar with the patient's history and other clinical signs and symptoms request verification of results with repeat sample collection and testing for inconsistent, unexplainable results prior to making clinical decisions. Good laboratory practice and regulatory requirements, mandates a system be in place for confirming and reporting abnormal values and/or significant changes in patient test results, employing user-defined delta checks, data and printout reviews, and correlation with peripheral smears. The user appropriately verified patient information prior to result reporting.
Patient Sequence No: 1, Text Type: N, H10
[133537318]
A user in (b)(6) reported the slide preparer incorrectly labeled patient slides. A sample was analyzed, and a slide was created. The slide preparer accurately labeled the slide. A second sample was analyzed, and a slide was created. The slide preparer incorrectly labeled the slide with the patient information from the previous sample. No analyzer errors were generated. The issue of incorrect slide labeling was obvious to the user. No erroneous results were reported and no corrected reports were issued. No negative impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000515253-2019-00002 |
| MDR Report Key | 8255041 |
| Date Received | 2019-01-16 |
| Date of Report | 2019-04-11 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2019-04-10 |
| Device Manufacturer Date | 2018-02-21 |
| Date Added to Maude | 2019-01-16 |
| 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 | MRS. JASNA FRONTZ |
| Manufacturer Street | 577 APTAKISIC RD |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 2245439753 |
| Manufacturer G1 | SYSMEX RA CO., LTD. MAIN PLANT |
| Manufacturer Street | 1850-3 HIROOKA-NOMURA |
| Manufacturer City | SHIOJIRI, NAGANO 399-0702 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 399-0702 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYSMEX SP-50 |
| Generic Name | AUTOMATED SLIDE PREPARATION UNIT |
| Product Code | KPA |
| Date Received | 2019-01-16 |
| Model Number | SP-50 |
| Catalog Number | BX765805 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX RA CO., LTD. MAIN PLANT |
| Manufacturer Address | 1850-3 HIROOKA-NOMURA SHIOJIRI, NAGANO 399-0702 JA 399-0702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-16 |