MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-24 for ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2) manufactured by Siemens Healthcare Diagnostics Inc..
[66031950]
The customer contacted a siemens customer care center (ccc) specialist. The customer reported that they obtained out of range quality control results and discordant results on patient samples when changing from one pair of iron_2 reagent 1 and reagent 2 over to the second pair of the onboard reagents. The customer performed calibration and reran the patient samples, which were lower. The cause of the discordant, falsely elevated iron_2 results on two patient samples is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[66031951]
The customer obtained discordant, falsely elevated iron_2 results on two patient samples on an advia 2400 instrument, when using reagent kit lot 139. The customer repeated the calibration and the patient samples on the same instrument and the patient sample results were lower. The initial results were reported to the physician(s). The repeat results were reported as corrected results to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated iron_2 results.
Patient Sequence No: 1, Text Type: D, B5
[66154572]
The initial mdr 2432235-2017-00077 was filed on january 24, 2017. Corrected information (01/27/2017): the initial mdr stated that the advia chemistry iron_2 reagents (iron_2) kit lot # was 139. The correct kit lot # is 383073.
Patient Sequence No: 1, Text Type: N, H10
[66154573]
The customer obtained discordant, falsely elevated iron_2 results on two patient samples on an advia 2400 instrument, when using reagent kit lot 383073. The customer repeated the calibration and the patient samples on the same instrument and the patient sample results were lower. The initial results were reported to the physician(s). The repeat results were reported as corrected results to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated iron_2 results.
Patient Sequence No: 1, Text Type: D, B5
[69974596]
The initial mdr 2432235-2017-00077 was filed on january 24, 2017. The first supplemental mdr 2432235-2017-00077_s1 was filed on january 27, 2017. Additional information (02/13/2017): the customer stated that they have now been mixing reagents prior to placing them on-board. A siemens headquarters support center (hsc) specialist reviewed the data provided by the customer. The hsc specialist stated that there is no known reason for an impact on results by mixing. The hsc specialist stated that there was no reagent issue. The cause of the discordant, falsely elevated iron_2 results on two patient samples is unknown. The device is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
[74614722]
The initial mdr 2432235-2017-00077 was filed on january 24, 2017. The first supplemental mdr 2432235-2017-00077_s1 was filed on january 27, 2017. The second supplemental mdr 2432235-2017-00077_s2 was filed on march 10, 2017. Additional information (03/29/2017): the customer stated that the patient samples were also impacted on two additional advia chemistry instruments. The customer did not provide patient data.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2017-00077 |
| MDR Report Key | 6274084 |
| Date Received | 2017-01-24 |
| Date of Report | 2017-04-20 |
| Date of Event | 2016-12-29 |
| Date Mfgr Received | 2017-03-29 |
| Date Added to Maude | 2017-01-24 |
| 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 | 3 |
| Brand Name | ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2) |
| Generic Name | ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2) |
| Product Code | CIX |
| Date Received | 2017-01-24 |
| Model Number | ADVIA CHEMISTRY IRON_2 REAGENTS (IRON_2) |
| Lot Number | 383073 |
| 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 INC. |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-24 |