MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-04-03 for SYSMEX POCH-100I ANALYZER POCH-1000I 023-1861-8 manufactured by Sysmex Corp.
[19687370]
The operator reported that the thermal printout on their poch-100i automated hematology analyzer intermittently displayed a neutrophil percentage (neut%) from the white blood cell (wbc) differential without a decimal point. The value was correct, but lacked the decimal causing the neut% to be a nonsensical value. The printouts were from the qc mode, and no impact to pt treatment as a result of the missing decimal point was alleged. The complaint was escalated to sysmex corp (b)(4) (scj) for further investigation.
Patient Sequence No: 1, Text Type: D, B5
[19839391]
Sc(b)(4) informed sysmex america, inc on 03/04/2013, that the investigation confirmed there was potential to omit a character, which could be a decimal, a number, or part of the graphics from the printout due to a defect in the printed circuit board (pcb) of the internal printer. This omission of a character is limited to the thermal printout and does not affect the lcd display or data output of results. The probability of occurrence was estimated as one time out of 2000 measurements. The product problem was identified as a defect of the printed circuit board (pcb) of the internal printer. A correction of the affected poch-100i analyzers will be performed by replacing the printer pcb. Operators of the 121 affected devices will be informed of a temporary countermeasure; to verify the printout against the lcd display, or against the data transmitted to the lab info system until the pcb can be replaced. The correction by pcb replacement is targeted to be completed in the next 90 days.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1422681-2013-00006 |
| MDR Report Key | 3040272 |
| Report Source | 05,06 |
| Date Received | 2013-04-03 |
| Date of Report | 2012-11-30 |
| Date of Event | 2012-11-30 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2013-06-03 |
| 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 | PETER OSELLA, VP |
| Manufacturer Street | 577 APTAKISIC RD |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 8479964512 |
| Manufacturer G1 | SYSMEX CORP |
| Manufacturer Street | 1-5-1 WAKINOHAMA--KAIGANDORI CHUO-KU |
| Manufacturer City | KOBE 651-0073 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 651-0073 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSMEX POCH-100I ANALYZER |
| Generic Name | AUTOMATED HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2013-04-03 |
| Model Number | POCH-1000I |
| Catalog Number | 023-1861-8 |
| Lot Number | F1844 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX CORP |
| Manufacturer Address | KOBE JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-03 |