MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-22 for ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2) manufactured by Siemens Healthcare Diagnostics Inc..
[78367728]
The customer contacted a siemens customer care center and stated that they noted more than usual numbers for low iron_2 results in the centralink validation queue. The customer ran quality control, which was out of range. The customer believes that the issue occurred after they changed the reagent bottle. The customer calibrated the assay and reran quality controls, which were within acceptable range. The customer repeated the patient samples post calibration and obtained acceptable results. The customer stated that the issue was resolved by having one pair of reagent on board at a time and inverting it several times before placing it on board. As per the advia chemistry iron_2 instructions for use, "siemens recommends calibrating new reagent packs if the previous reagent pack was recalibrated any time during its on-board stability, other than as a fresh pack. " the customer does not follow this recommendation. Additionally, the customer does not always mix reagents when placed on-board. A siemens headquarters support center (hsc) specialist reviewed the information provided and stated that the data showed a constant bias between initial and repeat results, indicating calibration issue with an open vial of reagent. The hsc specialist stated that this issue was not due to reagent issue. The hsc specialist concluded that the issue may have occurred due to difference in performance with a partially used vial versus a fresh vial which can impact calibrator recovery. The cause of the discordant, falsely low iron_2 results on one patient sample is unknown. The device is performing within manufacturing specifications. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[78367729]
The customer obtained discordant, falsely low iron_2 results on multiple patient samples on an advia 2400 instrument, while using reagent kit lot # 393998. The samples were repeated on the alternate advia chemistry instruments, resulting higher. The initial results for sample ids (b)(6) were reported to the physician(s). The corrected results for sample ids (b)(6) were reported to the physician(s). It is unknown which results were reported for sample ids (b)(6). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low iron_2 results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00379 |
| MDR Report Key | 6661581 |
| Date Received | 2017-06-22 |
| Date of Report | 2017-06-22 |
| Date of Event | 2017-05-29 |
| Date Mfgr Received | 2017-05-30 |
| Date Added to Maude | 2017-06-22 |
| 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 | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | RANDOX LABORATORIES LTD. |
| Manufacturer Street | REGISTRATION # 8020890 55 DIAMOND ROAD |
| Manufacturer City | CRUMLIN, CO. ANTRIM BT294QY |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BT29 4QY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2) |
| Generic Name | ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2) |
| Product Code | CIX |
| Date Received | 2017-06-22 |
| Model Number | ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2) |
| Lot Number | 393998 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-22 |