MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-05-05 for IMMULITE/IMMULITE 1000 IGF-1 manufactured by Siemens Healthcare Diagnostics Products Limited.
[44555413]
Siemens headquarters support center (hsc) has reviewed the data provided by the customer. Igf-1 reagent lot 411 which contains pretreatment lot 55 has expired as of 4/30/2016. Testing carried out by siemens technical operations has showed that samples reach equilibrium state after 24 minutes of pre-treatment time and remained stable up to 3 hours and 12 minutes. As the igf-1 reagent lot has expired, sample handling, and sample specific issues cannot be determined as no further in-house testing is possible. The customer will be provided the next reagent lot for use at their site. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[44555414]
The customer has carried out a time study on pre-treatment times on two patient samples for the insulin growth factor assay (igf-1) on an immulite 1000 instrument using reagent lot 411. Based on the data obtained, the customer has indicated that they observe a drift in values after the 24 minutes of pre-treatment as indicated in ufsn # imc16-05. A. Ous sent out in april of 2016. It is unknown if the results obtained on the two patient samples tested were released to the physician(s). There were no reports of patient intervention or adverse health consequences due to the drift observed in the igf-1 values.
Patient Sequence No: 1, Text Type: D, B5
[45804813]
A ufsn and umdc was sent out to ous and us customers respectively in april of 2016. The letter informs the customers of the following information: siemens healthcare diagnostics has determined that it takes 24 minutes of incubation prior to processing the samples on the immulite/immulite 1000 system for the patient sample and the pretreatment solution to reach full equilibration when using pretreatment solution (lgfa) lot 055 contained in igf-i kit lot 411 (expiration 4/30/2016). If patient samples are run before reaching full equilibration an under-recovery of up to -36% may occur. If the sample is left to incubate for more than 24 minutes prior to testing, no under recovery is observed. Quality controls (qc) will not detect this issue. No other immulite/immulite 1000 igf-i kit lots are affected as lot 055 igf-i pretreatment solution is only contained in immulite/immulite 1000 igf-i kit lot 411. Additional information (5/13/2016): igf kit lot 411 containing pretreatment lot 55 has expired as of 4/30/2016. No further testing can be done. Internal testing for this issue showed that the samples reached equilibrium after 24 minutes of incubation and results remained stable at testing up to 3 hours and 12 minutes. As per ufsn imc16-05. A. Ous, potential clinical impact is mitigated by serial monitoring of serum igf-i as well as correlation to serum growth hormone measurements and clinical presentation. The customer has moved on to a new reagent lot and the results obtained with the new lot are acceptable to the customer. Additional information (5/18/2016): the customer has informed siemens the patient samples used for testing were part of a study as they are a research lab. Results are not being reported out to physician(s). No further evaluation of the device is required. The system is performing according to specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00234 |
| MDR Report Key | 5634851 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-05 |
| Date of Report | 2016-05-24 |
| Date of Event | 2016-04-25 |
| Date Mfgr Received | 2016-05-13 |
| Date Added to Maude | 2016-05-05 |
| 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 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED |
| Manufacturer Street | GLYN RHOWNY, LLANBERIS GWYNEDD, CAERNARFON |
| Manufacturer City | WALES LL55 4EL, UK, LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-04/19/2016-004-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE/IMMULITE 1000 IGF-1 |
| Generic Name | IMMULITE/IMMULITE 1000 IGF-1 |
| Product Code | CFL |
| Date Received | 2016-05-05 |
| Model Number | IMMULITE/IMMULITE 1000 IGF-1 |
| Lot Number | 411 |
| 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 LIMITED |
| Manufacturer Address | GLYN RHOWNY LLANBERIS, CAERNARFON GWYNEDD, WALES, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-05 |