MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-12-27 for BERICHROM HEPARIN 10446620 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[95905511]
A siemens healthcare diagnostics inc. (siemens) customer service engineer (cse) was dispatched to the customer's site to determine the cause of the discordant, falsely low heparin unfractionated (uf) result and quality control (qc) imprecision on the sysmex ca-1500 system. The cse observed a crack on the edge of the optical filter on the sysmex ca-1500 system and replaced the optical filter. The cse also verified the z adjustment on the piercer at the feeder position, verified that the lamp unit #3 box was internally clean, removed and cleaned filters, cleaned fiber end, verified the lamp stability, during the lamp calibration, with water in the 4 cuvettes, adjusted the reagent dispenser to the right of the center in the reaction vessel and lowered the reagent dispenser to miss the spring on catcher by 1 to 2 mm. After replacing the optical filter and performing the adjustments on the sysmex ca-1500 system, the cse ran calibration, qc, and performed three precision studies using control level 1, control level 2 and patient samples. The calibration, qc and precision studies recovered within expected ranges in micro mode and outside of expected ranges in normal mode. The operator declined further investigation and stopped running the heparin uf assay. The filter malfunction potentially contributed to the discordant result and qc imprecision. No further evaluation of these systems or reagent is required.
Patient Sequence No: 1, Text Type: N, H10
[95905512]
Imprecise and out of range heparin unfractionated (uf) quality control (qc) results were obtained on the sysmex ca-1500 system. During this time, a patient sample was tested for heparin uf, resulting in a discordant, falsely low heparin uf result. This result was reported to the physician, who did not question the result. The patient's blood was redrawn and run on an alternate system, sysmex ca-1500 system, using same reagent lot. A higher heparin uf result, within therapeutic range, was obtained using the alternate system. It is unknown if the redrawn result was the correct result as the operator was also experiencing issues with the alternate system. The operator indicated that a corrected report was provided for this patient as the pharmacy indicated that the patient was on heparin treatment when the discordant result was reported. However, the corrected result is unknown. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low heparin uf result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00151 |
| MDR Report Key | 7149214 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-27 |
| Date of Report | 2018-02-02 |
| Date of Event | 2017-12-01 |
| Date Mfgr Received | 2018-01-08 |
| Date Added to Maude | 2017-12-27 |
| 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 | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING- STR. 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BERICHROM HEPARIN |
| Generic Name | BERICHROM HEPARIN |
| Product Code | KFF |
| Date Received | 2017-12-27 |
| Model Number | BERICHROM HEPARIN |
| Catalog Number | 10446620 |
| Lot Number | 47293 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-27 |